A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

Study Identifier
RLM-MD-01
CT.gov Identifier
NCT03285308
EudraCT Identifier
2017-002136-16
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Other
Sign up for trial alerts

Results Available

Protocol
Available Language(s): English
Download document(s)
Statistical Analysis Plan
Available Language(s): English
Download document(s)

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
    University of Alabama at Birmingham
    Birmingham, Alabama, United States, 35295
    Status
    Not applicable
    Location
    Digestive Health Specialist of the South East
    Dothan, Alabama, United States, 36305
    Status
    Not applicable
    Location
    Avant Research Associates
    Huntsville, Alabama, United States, 35801
    Status
    Not applicable
    Location
    Synexus Clinical Research US, Inc.
    Fountain Hills, Arizona, United States, 85268
    Status
    Not applicable
    Location
    Central Arizona Medical Associates
    Mesa, Arizona, United States, 85206
    Status
    Not applicable
    Location
    Phoenix Clinical LLC
    Phoenix, Arizona, United States, 85014
    Status
    Not applicable
    Showing {first} - {last} of {total} Results