Diabetic Gastroparesis Study 05

Stopped early · Phase 3

Conditions studied: Gastroparesis

In brief

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.

Key facts

Study ID

NCT03786380

Run by

Allergan

People needed

202

Starts

2018-12-20

Expected to finish

2020-10-05

Last updated by the study team

2021-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Digestive Health Specialist of the South East — Dothan, Alabama, United States
• G & L Research, LLC — Foley, Alabama, United States
• Alabama Medical Group, PC — Mobile, Alabama, United States
• Del Sol Research Management, LLC — Chandler, Arizona, United States
• Phoenix Clinical LLC. — Phoenix, Arizona, United States
• Pinnacle Research Group — Anniston, Alabama, United States
• Adobe Clinical Research LLC — Tucson, Arizona, United States
• Del Sol Research Management, LLC — Tucson, Arizona, United States
• Preferred Clinical Research Partners — Little Rock, Arkansas, United States
• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• HCP Clinical Research LLC — Anaheim, California, United States
• Hope Clinical Research — Canoga Park, California, United States
• GW Research Inc — Chula Vista, California, United States
• Kindred Medical Institute for Clinical Trials, LLC — Corona, California, United States
• Aurora Care Clinic, LLC — Costa Mesa, California, United States
• Diagnamics Inc. — Encinitas, California, United States
• Valley View Wellness and Medical Center - VVCRD Clinical Research — Garden Grove, California, United States
• University of California San Diego — La Jolla, California, United States
• Om Research LLC — Lancaster, California, United States
• Torrance Clinical Research Institute, Inc. — Lomita, California, United States
• Tibor Rubin VA Medical Center — Long Beach, California, United States
• Angel City Research Inc. — Los Angeles, California, United States
• North Alabama Research Center, LLC — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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