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

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

sites

Long Island Gastrointestinal Research Group, LLP

Great Neck, New York 11023

from

Great Neck, NY