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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/NCT03285308
Registration number
NCT03285308
Ethics application status
Date submitted
14/09/2017
Date registered
18/09/2017
Date last updated
29/07/2021
Titles & IDs
Public title
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01
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Scientific title
A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
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Secondary ID [1]
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2017-002136-16
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Secondary ID [2]
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RLM-MD-01
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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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0
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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: Placebo - Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
Experimental: Relamorelin 10 µg - Following a 2-week placebo run-in, participants received relamorelin 10 µg injected subcutaneously twice daily for up to 12 weeks.
Treatment: Drugs: Placebo
Placebo injected subcutaneously twice daily.
Treatment: Drugs: Relamorelin
Relamorelin 10 micrograms (µg) injected subcutaneously 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)
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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.
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Timepoint [1]
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Baseline (Day-14 to Day-1) to Week 12
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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 12-week 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 12-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 12-week 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 12-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.
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Timepoint [1]
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Baseline (Day-14 to Day-1) 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 12-week 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 12-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.
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Timepoint [2]
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Baseline (Day-14 to Day-1) 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 12-week 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 12-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.
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Timepoint [3]
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Baseline (Day-14 to Day-1) 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 12-week 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 12-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).
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Timepoint [4]
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Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
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Secondary outcome [5]
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Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
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Assessment method [5]
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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 [5]
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Up to approximately 16 weeks
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Secondary outcome [6]
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Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
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Assessment method [6]
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Clinical Laboratory tests 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 [6]
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Up to 12 weeks
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Secondary outcome [7]
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Number of Participants With Clinically Meaningful Trends for Vital Signs
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Assessment method [7]
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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 [7]
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Up to 12 weeks
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Secondary outcome [8]
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Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
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Assessment method [8]
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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 [8]
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Up to 12 weeks
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Secondary outcome [9]
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Number of Participants With a =1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
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Assessment method [9]
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HbA1c is also known as glycosylated hemoglobin. It is the concentration of glucose bound to hemoglobin as a percentage of the absolute maximum that can be bound.
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Timepoint [9]
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Baseline (Day 1) up to 12 weeks
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Secondary outcome [10]
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Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
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Assessment method [10]
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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. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.
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Timepoint [10]
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Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84)
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Eligibility
Key inclusion criteria
- Diagnosis of Type 1 or Type 2 diabetes mellitus
- Meet the per protocol criteria of diabetic gastroparesis
- Compliance with diary
- Compliance with the per protocol study treatment dosing instructions
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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
- Currently receiving nutrition intravenously, by nasogastric tube, or other feeding
tube
- Actively experiencing anorexia nervosa, binge-eating, bulimia, or other eating
disorder at the time of Screening (Visit 1)
- Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
- History of gastrointestinal disorders that may be similar to gastroparesis
- Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
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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 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
29/09/2017
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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
8/07/2020
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Sample size
Target
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Accrual to date
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Final
336
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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 - Central Adelaide Local Health Network Incorporated - Adelaide
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Recruitment hospital [3]
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The Alfred Hospital - Melbourne
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Recruitment hospital [4]
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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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3004 - Melbourne
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Recruitment postcode(s) [4]
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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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Nantes Cedex 1
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India
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Madurai
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New Delhi
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Beer Sheba
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Holon
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Israel
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Petach Tikva
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Israel
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Safed
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Israel
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Tel Aviv
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Korea, Republic of
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Jeollabuk-Do
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Nowon-gu
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Seoul
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Kedah
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Taiping
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Manila
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Philippines
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Metro Manila
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Philippines
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NCR
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Philippines
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Philippines
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Quezon City
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Gdansk
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Bialystok
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Chojnice
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Czestochowa
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Kraków
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Wroclaw
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Singapore
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Singapore
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Madrid
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Spain
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Salamanca
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Spain
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Sevilla
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Bangkok
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Thailand
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Chiang Mai
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Ukraine
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Odesa Region
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Ukraine
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Vinnyts'ka Oblast'
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Ukraine
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Zaporizhzhia Region
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Ukraine
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Chernivtsi
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Ukraine
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Dnipro
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kherson
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Ukraine
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Kyiv
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Ukraine
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Odesa
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Ukraine
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Poltava
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Ukraine
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Ternopil
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Country [101]
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Ukraine
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State/province [101]
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Vinnytsia
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Country [102]
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Ukraine
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State/province [102]
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Zaporizhzhia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Ethics approval
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Summary
Brief summary
This study will evaluate the safety and efficacy of relamorelin compared to placebo in
participants with diabetic gastroparesis. Participants will report daily severity scores of
their diabetic gastroparesis symptoms.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03285308
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Wieslaw (Wes) Bochenek, MD, PhD
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Address
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Allergan
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03285308
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