Status:
TERMINATED
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03
Lead Sponsor:
Allergan
Conditions:
Gastroparesis
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 conti...
Eligibility Criteria
Inclusion
- Participants are eligible to be included in the study only if all the following criteria apply:
- Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study
- Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
- In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02
Exclusion
- Participants are excluded from the study if any of the following criteria apply:
- Participant is not willing or able to abide by the restrictions regarding concomitant medicine use
- Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03
- Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study
- Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease
Key Trial Info
Start Date :
January 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
467 Patients enrolled
Trial Details
Trial ID
NCT03420781
Start Date
January 24 2018
End Date
October 30 2020
Last Update
December 22 2021
Active Locations (337)
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1
North Alabama Research Center, LLC
Athens, Alabama, United States, 35611
2
Digestive Health Specialist of the South East
Dothan, Alabama, United States, 36305
3
G & L Research, LLC
Foley, Alabama, United States, 36535
4
Alabama Medical Group, PC
Mobile, Alabama, United States, 36608