DRUG
Relamorelin 10 μg
Relamorelin 10 μg injected subcutaneously twice daily.
Status
Terminated
Phase
Phase 3
Enrollment
202
Locations
486
Results
Posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Dec 26, 2018
Study start
Dec 20, 2018
Primary completion
Oct 5, 2020
Study completion
Oct 5, 2020
Results posted
Dec 15, 2021
Registry updated
Dec 15, 2021
Outcomes
What the study measures.
Primary outcomes
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
Time frame · 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
Time frame · 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 for Vital Signs
Time frame · 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.
Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results
Time frame · Up to approximately 22 months
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
486 registered sites.
Argentina · Australia · Austria · Belgium · Brazil · Bulgaria · Canada · Colombia · Denmark · France · Germany · Hungary · India · Israel · Italy · Latvia · Malaysia · Mexico · Philippines · Poland · Romania · Russia · Singapore · South Africa · South Korea · Spain · Thailand · Ukraine · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Chandler, Arizona, United States
Phoenix Clinical LLC.
Phoenix, Arizona, United States
Adobe Clinical Research LLC
Tucson, Arizona, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
Preferred Clinical Research Partners
Little Rock, Arkansas, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
HCP Clinical Research LLC
Anaheim, California, United States
Hope Clinical Research
Canoga Park, California, United States
GW Research Inc
Chula Vista, California, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, United States
Aurora Care Clinic, LLC
Costa Mesa, California, United States
Diagnamics Inc.
Encinitas, California, United States
Valley View Wellness and Medical Center - VVCRD Clinical Research
Garden Grove, California, United States
University of California San Diego
La Jolla, California, United States
Om Research LLC
Lancaster, California, United States
Torrance Clinical Research Institute, Inc.
Lomita, California, United States
Tibor Rubin VA Medical Center
Long Beach, California, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Relamorelin.
NCT IDStudyPhase / statusEnrollmentUpdated
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03
Allergan · Gastroparesis · Diabetes Mellitus
Phase 3
Terminated
467
2021-12
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04
Allergan · Gastroparesis · Diabetes Mellitus
Phase 3
Terminated
450
2021-11
Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02
Allergan · Gastroparesis · Diabetes Mellitus
Phase 3
Terminated
311
2021-08
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01
Allergan · Gastroparesis · Diabetes Mellitus
Phase 3
Terminated
336
2021-07
Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
Allergan · Diabetes Mellitus · Diabetes Mellitus Complications
Phase 2
Completed
393
2019-07
Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
Motus Therapeutics, Inc. · Diabetes Mellitus · Diabetes Mellitus Complications
Phase 2
Completed
204
2016-09
Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa
Motus Therapeutics, Inc. · Anorexia Nervosa
Phase 2
Completed
20
2016-09
Phase 2 Study to Evaluate Safety and Efficacy of RM-131 Administered to Patients With Chronic Constipation
Motus Therapeutics, Inc. · Constipation
Phase 2
Completed
48
2016-09
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.