A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

Allergan

Status and phase: Terminated; Phase 3

Conditions: Gastroparesis; Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Relamorelin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03420781

RLM-MD-03

Details and patient eligibility

About

A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.

Enrollment: 467 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants are eligible to be included in the study only if all the following criteria apply:
• Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study
• Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
• In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02

Exclusion criteria

• Participants are excluded from the study if any of the following criteria apply:
• Participant is not willing or able to abide by the restrictions regarding concomitant medicine use
• Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03
• Participant has an unresolved adverse event (AE) or 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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467 participants in 5 patient groups, including a placebo group

Treatment Period: Placebo

Placebo Comparator group

Description:

Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.

Treatment:

Drug: Placebo

Treatment Period: Relamorelin 10 μg

Experimental group

Description:

Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 40 weeks.

Treatment:

Drug: Relamorelin

Randomized Withdrawal Period: Placebo then Relamorelin 10 μg

Experimental group

Description:

Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period.

Treatment:

Drug: Placebo

Drug: Relamorelin

Randomized Withdrawal Period: Relamorelin 10 μg then Relamorelin 10 μg

Experimental group

Description:

Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.

Treatment:

Drug: Relamorelin

Randomized Withdrawal Period: Relamorelin 10 μg then Placebo

Experimental group

Description:

Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.

Treatment:

Drug: Placebo

Drug: Relamorelin