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NCT03383146 · ClinicalTrials.gov registry record · Phase 3
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04
A Phase 3 study, sponsored by Allergan.
- Terminated
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
NCT03383146: Clinical Trial Phase 3 study, sponsored by Allergan.
NCT03383146 is a Phase 3 study that was terminated before completion, run by Allergan. The registered enrollment target is 450 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03383146, a Phase 3 study, was terminated before completion, sponsored by Allergan.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
Study Summary
A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.
Primary Outcome
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)
Interventions
- DRUG Placebo
- DRUG Relamorelin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2020-11-05 |
| Phase | Phase 3 |
Why NCT03383146 stopped before completion
NCT03383146 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03383146 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03383146 about?
NCT03383146 is a clinical study titled "A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04". A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.
What is the current status of trial NCT03383146?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2018-02-01. Estimated completion is 2020-11-05.
What interventions are being tested in trial NCT03383146?
The interventions under investigation include: Placebo (DRUG), Relamorelin (DRUG).
Who is sponsoring clinical trial NCT03383146?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03383146's enrollment target sits among peer trials
450 837th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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