Diabetic Gastroparesis Study 05

Phase 3

Terminated

• Conditions: Gastroparesis
• Interventions: Drug: Relamorelin 10 μg

• Registration Number: NCT03786380
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-20
• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2018-12-21
• Study First Posted: 2018-12-26
• Primary Completion: 2020-10-05
• Study Completion: 2020-10-05
• Results First Submitted: 2021-10-05
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-19
• Last Update Submitted: 2021-11-19
• Results First Posted: 2021-12-15
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 202

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Relamorelin 10 μg	Relamorelin 10 μg	Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to approximately 22 months.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)	Up to approximately 22 months	An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results	Baseline (Day 1) up to approximately 22 months	Clinical Laboratory tests included hematology, chemistry and urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results	Up to approximately 22 months	A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Number of Participants With Clinically Meaningful Trends for Vital Signs	Up to approximately 22 months	Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.

Trial Locations

Locations (483)

Pinnacle Research Group; 🇺🇸 Anniston, Alabama, United States

North Alabama Research Center, LLC; 🇺🇸 Athens, Alabama, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Digestive Health Specialist of the South East; 🇺🇸 Dothan, Alabama, United States

G & L Research, LLC; 🇺🇸 Foley, Alabama, United States

Alabama Medical Group, PC; 🇺🇸 Mobile, Alabama, United States

Del Sol Research Management, LLC; 🇺🇸 Tucson, Arizona, United States

Phoenix Clinical LLC.; 🇺🇸 Phoenix, Arizona, United States

Adobe Clinical Research LLC; 🇺🇸 Tucson, Arizona, United States

Preferred Clinical Research Partners; 🇺🇸 Little Rock, Arkansas, United States

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