Diabetic Gastroparesis Study 05

Allergan

Status and phase

Terminated

Phase 3

Conditions

Gastroparesis

Treatments

Drug: Relamorelin 10 μg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03786380

2019-000406-30 (EudraCT Number)

3071-305-020

Details and patient eligibility

About

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.

Enrollment

202 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 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 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.