Diabetic Gastroparesis Study 05



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:December 20, 2018
End Date:December 23, 2023
Contact:Clinical Trials Registry Team
Email:IR‐CTRegistration@Allergan.com
Phone:877‐277‐8566

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Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis

This open-label study is to assess the safety of continued treatment with Relamorelin for
participants who previously completed the RLM-MD-03 or RLM-MD-04 study and to provide
treatment for these participants until Relamorelin becomes commercially available or the
Sponsor terminates development.


Inclusion Criteria:

- Successful completion of either Study RLM-MD-03 or Study RLM-MD-04

- Ability to provide written 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 Criteria:

- 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 AE from a lead-in study, ie, a clinically significant
finding on physical examination, clinical laboratory test, or 12-lead 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
We found this trial at
3
sites
10555 West Flagler Street
Miami, Florida 33174
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Great Neck, NY
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Monroe, LA
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