Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02

Study Identifier
RLM-MD-02
CT.gov Identifier
NCT03426345
EudraCT Identifier
2017-002177-20
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Study Details

Medical Condition
  • Digestive & Intestinal - Other
  • Diabetes
    • Study Drug
  • Placebo
  • Relamorelin
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of Type 1 or Type 2 diabetes mellitus * Meet the per protocol criteria of diabetic gastroparesis * Compliance with diary * Compliance with the per protocol study treatment dosing instructions
    Exclusion Criteria:
    * Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube * Actively experiencing anorexia nervosa, binge-eating, bulimia or other eating disorder at the time of Screening (Visit 1) * Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity * History of gastrointestinal disorders that may be similar to gastroparesis * Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus

    Protocol Summary

    This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

    Study Locations

    Location
    Status
    Location
    North Alabama Research Center, LLC
    Athens, Alabama, United States, 35611
    Status
    Not applicable
    Location
    Synexus Clinical Research US - Simon Williamson Clinic
    Birmingham, Alabama, United States, 35211
    Status
    Not applicable
    Location
    G & L Research, LLC
    Foley, Alabama, United States, 36535
    Status
    Not applicable
    Location
    Alabama Medical Group, PC
    Mobile, Alabama, United States, 36608
    Status
    Not applicable
    Location
    Synexus Clinical Research US, Inc.
    Tucson, Arizona, United States, 85741
    Status
    Not applicable
    Location
    Applied Research Center of Arkansas
    Little Rock, Arkansas, United States, 72212
    Status
    Not applicable
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