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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03420781
Registration number
NCT03420781
Ethics application status
Date submitted
24/01/2018
Date registered
5/02/2018
Date last updated
22/12/2021
Titles & IDs
Public title
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03
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Scientific title
A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
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Secondary ID [1]
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RLM-MD-03
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastroparesis
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Diabetes Mellitus
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Relamorelin
Placebo Comparator: Treatment Period: Placebo - Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.
Experimental: Treatment Period: Relamorelin 10 µg - Relamorelin 10 micrograms (µg) injected subcutaneously twice daily for up to 40 weeks.
Experimental: Randomized Withdrawal Period: Placebo then Relamorelin 10 µg - Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 µg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period.
Experimental: Randomized Withdrawal Period: Relamorelin 10 µg then Relamorelin 10 µg - Participants who received relamorelin 10 µg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.
Experimental: Randomized Withdrawal Period: Relamorelin 10 µg then Placebo - Participants who received relamorelin 10 µg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Treatment: Drugs: Placebo
Placebo injected twice daily
Treatment: Drugs: Relamorelin
Relamorelin 10 µg injected twice daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period
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Assessment method [1]
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Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
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Timepoint [1]
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Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study
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Primary outcome [2]
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Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
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Assessment method [2]
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The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period.
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Timepoint [2]
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Week 6 to Week 12
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Secondary outcome [1]
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Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
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Assessment method [1]
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A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no nausea to 10=worst possible nausea. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
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Timepoint [1]
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Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
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Secondary outcome [2]
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Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
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Assessment method [2]
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An Abdominal Pain Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for abdominal pain at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Abdominal pain was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no abdominal pain to 10=the worst possible abdominal pain and was recorded in an e-diary. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
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Timepoint [2]
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Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
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Secondary outcome [3]
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Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
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Assessment method [3]
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A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Bloating was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no bloating and 10=the worst possible bloating and was recorded in the e-diary. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
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Timepoint [3]
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Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
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Secondary outcome [4]
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Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
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Assessment method [4]
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A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Postprandial Fullness was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no feeling of fullness until finishing a meal (best) to 10=feeling full after only a few bites (worst). Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
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Timepoint [4]
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Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
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Secondary outcome [5]
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Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period
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Assessment method [5]
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Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an e-diary. The DGSSS was derived as the sum of the weekly averages (Week 37 to Week 40) of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous studies.
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Timepoint [5]
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Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
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Secondary outcome [6]
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Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period
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Assessment method [6]
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The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during the last 4 weeks of the 40-week Treatment Period.
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Timepoint [6]
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Week 37 to Week 40
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Secondary outcome [7]
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Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period
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Assessment method [7]
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The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. The average weekly number of vomiting episodes were derived as the average of the weekly number of vomiting episodes in the last 4 weeks of the 40-week Treatment Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
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Timepoint [7]
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Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
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Secondary outcome [8]
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Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period
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Assessment method [8]
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Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an e-diary. The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). Average weekly scores are derived as the average of the weekly scores from the 6 weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
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Timepoint [8]
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Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)
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Secondary outcome [9]
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Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period
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Assessment method [9]
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The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. Average weekly number of vomiting episodes are derived as the average of the weekly number of vomiting episodes from the six weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
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Timepoint [9]
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Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)
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Secondary outcome [10]
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Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
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Assessment method [10]
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An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
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Timepoint [10]
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First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks)
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Secondary outcome [11]
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Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
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Assessment method [11]
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Clinical Laboratory values included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
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Timepoint [11]
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Up to 46 weeks
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Secondary outcome [12]
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Number of Participants With Clinically Meaningful Trends for Vital Signs
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Assessment method [12]
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Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the results were clinically significant.
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Timepoint [12]
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Up to 46 weeks
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Secondary outcome [13]
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Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
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Assessment method [13]
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A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
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Timepoint [13]
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Up to 46 weeks
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Secondary outcome [14]
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Number of Participants With a =1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
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Assessment method [14]
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Timepoint [14]
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Up to 46 weeks
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Secondary outcome [15]
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Number of Participants With Anti-relamorelin Antibody Testing Results
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Assessment method [15]
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A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay.
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Timepoint [15]
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Up to 46 weeks
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Eligibility
Key inclusion criteria
- Participants are eligible to be included in the study only if all the following
criteria apply:
- Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01
(NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study
- Able to provide written informed consent (IC) prior to any study procedures and
willing and able to comply with study procedures
- In the opinion of the investigator, the participant demonstrated adequate compliance
with the study procedures in Study RLM-MD-01 or RLM-MD-02
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participants are excluded from the study if any of the following criteria apply:
- Participant is not willing or able to abide by the restrictions regarding concomitant
medicine use
- Participant is planning to receive an investigational drug (other than study
treatment) or investigational device at any time during Study RLM-MD-03
- Participant has an unresolved adverse event (AE) or a clinically significant finding
on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG)
that, in the investigator's opinion, would limit the participant's ability to
participate in or complete the study
- Any other reason that, in the investigator's opinion, would confound proper
interpretation of the study or expose a participant to unacceptable risk, including
renal, hepatic or cardiopulmonary disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/01/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/10/2020
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Sample size
Target
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Accrual to date
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Final
467
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Nepean Hospital - Kingswood
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Recruitment hospital [2]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [3]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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2747 - Kingswood
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Massachusetts
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Nebraska
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Nevada
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New Jersey
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New York
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South Dakota
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West Virginia
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Argentina
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Buenos Aires Province
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Argentina
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Cordoba
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Argentina
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Santa Fe
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Argentina
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Tucuman
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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Corrientes
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Austria
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Styria
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Austria
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Vorarlberg
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Austria
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Salzburg
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Austria
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Steyr
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Belgium
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Antwerp
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Belgium
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Brussel
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Belgium
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Brazil
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Ceara
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Brazil
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Ceará
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Brazil
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Distrito Federal
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Brazil
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Rio Grande Do Sul
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0
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Brazil
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0
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Santa Catarina
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0
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Brazil
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0
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Sao Paulo
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0
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Brazil
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São Paulo
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0
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Brazil
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0
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Belém
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0
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Bulgaria
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0
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Ruse
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0
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Bulgaria
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0
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Plovdiv
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0
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Canada
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0
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Alberta
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0
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Canada
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0
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British Columbia
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0
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Canada
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0
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Nova Scotia
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Funding & Sponsors
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Allergan
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Summary
Brief summary
A 46-week study to compare the efficacy of relamorelin with that of placebo in participants
with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants
will either continue on relamorelin or placebo for 6 additional weeks.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03420781
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Wieslaw Bochenek
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Allergan
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03420781
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