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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/NCT03786380




Registration number
NCT03786380
Ethics application status
Date submitted
21/12/2018
Date registered
26/12/2018
Date last updated
15/12/2021

Titles & IDs
Public title
Diabetic Gastroparesis Study 05
Scientific title
Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis
Secondary ID [1] 0 0
2019-000406-30
Secondary ID [2] 0 0
3071-305-020
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroparesis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Relamorelin 10 µg

Experimental: Relamorelin 10 µg - Relamorelin 10 micrograms (µg) injected subcutaneously twice daily for up to approximately 22 months.


Treatment: Drugs: Relamorelin 10 µg
Relamorelin 10 µg injected subcutaneously twice daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to approximately 22 months
Primary outcome [2] 0 0
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Timepoint [2] 0 0
Baseline (Day 1) up to approximately 22 months
Primary outcome [3] 0 0
Number of Participants With Clinically Meaningful Trends for Vital Signs
Timepoint [3] 0 0
Up to approximately 22 months
Primary outcome [4] 0 0
Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results
Timepoint [4] 0 0
Up to approximately 22 months

Eligibility
Key inclusion criteria
- Successful completion of either Study RLM-MD-03 or Study RLM-MD-04

- Ability to provide written informed consent (IC) prior to any study procedures and
willingness and ability to comply with study procedures

- Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or
RLM-MD-04, in the opinion of the investigator.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant is planning to receive an investigational drug (other than study
intervention) or investigational device at any time during Study 3071-305-020

- Participant has an unresolved adverse event (AE) from a lead-in study, ie, 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

- Females who are pregnant, nursing, or planning a pregnancy during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/10/2020
Sample size
Target
Accrual to date
Final
202
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated - Adelaide
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
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Country [214] 0 0
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Kherson
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Poltava
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Sumy
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Staffordshire
Country [231] 0 0
United Kingdom
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Barnsley
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United Kingdom
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Blackpool
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United Kingdom
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Chelmsford
Country [234] 0 0
United Kingdom
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Edinburgh
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United Kingdom
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Leeds
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United Kingdom
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Liverpool
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United Kingdom
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London
Country [238] 0 0
United Kingdom
State/province [238] 0 0
Manchester
Country [239] 0 0
United Kingdom
State/province [239] 0 0
Newcastle upon Tyne
Country [240] 0 0
United Kingdom
State/province [240] 0 0
Nottingham
Country [241] 0 0
United Kingdom
State/province [241] 0 0
Stockton-on-Tees
Country [242] 0 0
United Kingdom
State/province [242] 0 0
Tooting
Country [243] 0 0
United Kingdom
State/province [243] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This open-label study is to assess the safety of continued treatment with relamorelin for
participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146]
study and to provide treatment for these participants until relamorelin becomes commercially
available or the Sponsor terminates development.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03786380
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Harvy Schneier
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03786380