Diabetic Gastroparesis Study 05

Study Identifier
3071-305-020
CT.gov Identifier
NCT03786380
EudraCT Identifier
2019-000406-30
EUCTIS ID
Not available
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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
    • Study Drug
  • Relamorelin 10 μg
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol Summary

    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 Locations

    Location
    Status
    Location
    Pinnacle Research Group
    Anniston, Alabama, United States, 36207
    Status
    Not applicable
    Location
    North Alabama Research Center, LLC
    Athens, Alabama, United States, 35611
    Status
    Not applicable
    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
    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
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