Diabetic Gastroparesis Study 05

Phase 3TerminatedNCT03786380

Allergan202 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

202

Conditions

Gastroparesis

Interventions

Relamorelin 10 μgDRUG

Relamorelin 10 μg injected subcutaneously twice daily.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (486)

Outcomes

Primary Outcomes

Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)

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.

Time frame: Up to approximately 22 months

Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results

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.

Time frame: Baseline (Day 1) up to approximately 22 months

Number of Participants With Clinically Meaningful Trends for Vital Signs

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.

Time frame: Up to approximately 22 months

Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results

A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.

Time frame: Up to approximately 22 months

Data from ClinicalTrials.gov

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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

...and 476 more locations