Status:
TERMINATED
Diabetic Gastroparesis Study 05
Lead Sponsor:
Allergan
Conditions:
Gastroparesis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Successful completion of either Study RLM-MD-03 or Study RLM-MD-04
- Ability to provide written informed consent (IC) prior to any study procedures and willingness and ability to comply with study procedures
- Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or RLM-MD-04, in the opinion of the investigator.
Exclusion
- Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study 3071-305-020
- Participant has an unresolved adverse event (AE) from a lead-in study, ie, 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
- Females who are pregnant, nursing, or planning a pregnancy during the study.
Key Trial Info
Start Date :
December 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2020
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT03786380
Start Date
December 20 2018
End Date
October 5 2020
Last Update
December 15 2021
Active Locations (486)
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1
Pinnacle Research Group
Anniston, Alabama, United States, 36207
2
North Alabama Research Center, LLC
Athens, Alabama, United States, 35611
3
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35295
4
Digestive Health Specialist of the South East
Dothan, Alabama, United States, 36305