Diabetic Gastroparesis Study 05
NCT03786380 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202
Last updated 2021-12-15
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.
Conditions
Interventions
- DRUG
-
Relamorelin 10 μg
Relamorelin 10 μg injected subcutaneously twice daily.
Sponsors & Collaborators
-
Allergan
lead INDUSTRY
Principal Investigators
-
Harvy Schneier · Allergan
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-20
- Primary Completion
- 2020-10-05
- Completion
- 2020-10-05
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Bulgaria
- Canada
- Colombia
- Denmark
- France
- Germany
- Hungary
- India
- Israel
- Italy
- Latvia
- Malaysia
- Mexico
- Philippines
- Poland
- Romania
- Russia
- Singapore
- South Africa
- South Korea
- Spain
- Thailand
- Ukraine
- United Kingdom
Study Locations
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