A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03
Status: | Enrolling by invitation |
---|---|
Conditions: | Gastrointestinal, Diabetes |
Therapuetic Areas: | Endocrinology, Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/1/2019 |
Start Date: | January 24, 2018 |
End Date: | December 6, 2020 |
A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
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.
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.
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
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Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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University of South Florida The University of South Florida is a high-impact, global research university...
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University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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4800 Alberta Avenue
El Paso, Texas 79905
El Paso, Texas 79905
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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1 Saint Vincent Circle
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
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