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
We found this trial at
173
sites
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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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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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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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 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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University of Louisville The University of Louisville is a state supported research university located in...
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