Diabetic Gastroparesis Study 05

• Status: Terminated
• Trial end date: 2020-10-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan

Criteria

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