Trials / Terminated
TerminatedNCT03420781
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03
A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 467 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo injected twice daily |
| DRUG | Relamorelin | Relamorelin 10 μg injected twice daily |
Timeline
- Start date
- 2018-01-24
- Primary completion
- 2020-10-30
- Completion
- 2020-10-30
- First posted
- 2018-02-05
- Last updated
- 2021-12-22
- Results posted
- 2021-12-22
Locations
337 sites across 26 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Denmark, Germany, Hungary, India, Israel, Latvia, Malaysia, Mexico, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Thailand, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03420781. Inclusion in this directory is not an endorsement.