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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2017-002136-16
Secondary ID [2] 0 0
RLM-MD-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroparesis 0 0
Diabetes Mellitus 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 - 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)
Timepoint [1] 0 0
Baseline (Day-14 to Day-1) to Week 12
Primary outcome [2] 0 0
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Timepoint [2] 0 0
Week 6 to Week 12
Secondary outcome [1] 0 0
Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Timepoint [1] 0 0
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Secondary outcome [2] 0 0
Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Timepoint [2] 0 0
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Secondary outcome [3] 0 0
Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Timepoint [3] 0 0
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Secondary outcome [4] 0 0
Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Timepoint [4] 0 0
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Secondary outcome [5] 0 0
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
Timepoint [5] 0 0
Up to approximately 16 weeks
Secondary outcome [6] 0 0
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Timepoint [6] 0 0
Up to 12 weeks
Secondary outcome [7] 0 0
Number of Participants With Clinically Meaningful Trends for Vital Signs
Timepoint [7] 0 0
Up to 12 weeks
Secondary outcome [8] 0 0
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Timepoint [8] 0 0
Up to 12 weeks
Secondary outcome [9] 0 0
Number of Participants With a =1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
Timepoint [9] 0 0
Baseline (Day 1) up to 12 weeks
Secondary outcome [10] 0 0
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
Timepoint [10] 0 0
Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/07/2020
Sample size
Target
Accrual to date
Final
336
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated - Adelaide
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03285308
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Wieslaw (Wes) Bochenek, MD, PhD
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/study/NCT03285308