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NCT03426345 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02
A Phase 3 study, sponsored by Allergan.
- Terminated
- Registry status
- Phase 3
- Development phase
- 311
- Enrollment target
NCT03426345: Clinical Trial Phase 3 study, sponsored by Allergan.
NCT03426345 is a Phase 3 study that was terminated before completion, run by Allergan. The registered enrollment target is 311 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03426345, a Phase 3 study, was terminated before completion, sponsored by Allergan.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 311 participants
- Enrollment target
Study 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.
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 | 311 participants |
| Start Date | 2018-02-16 |
| Est. Completion | 2020-07-16 |
| Phase | Phase 3 |
Why NCT03426345 stopped before completion
NCT03426345 is an interventional study that assigns participants to a tested intervention. The registered 311 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 (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03426345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03426345 about?
NCT03426345 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02". 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.
What is the current status of trial NCT03426345?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 311 participants. The study started on 2018-02-16. Estimated completion is 2020-07-16.
What interventions are being tested in trial NCT03426345?
The interventions under investigation include: Placebo (DRUG), Relamorelin (DRUG).
Who is sponsoring clinical trial NCT03426345?
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 NCT03426345's enrollment target sits among peer trials
311 1106th of 2000 higher than 894 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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