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Diabetic Gastroparesis Study 05

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03786380
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This open-label study is to assess the safety of continued treatment with Relamorelin for participants who previously completed the RLM-MD-03 or RLM-MD-04 study and to provide treatment for these participants until Relamorelin becomes commercially available or the Sponsor terminates development.

Condition or disease Intervention/treatment Phase
Gastroparesis Drug: Relamorelin 10 μg Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : December 23, 2023
Estimated Study Completion Date : December 23, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Relamorelin 10 μg
Relamorelin 10 μg injected subcutaneously twice daily.
Drug: Relamorelin 10 μg
Relamorelin 10 μg injected subcutaneously twice daily.




Primary Outcome Measures :
  1. Proportion of adverse events in participants [ Time Frame: Through study completion: up to 5 years ]
  2. Proportion of abnormal clinical laboratory values [ Time Frame: Baseline and every 3 months for up to 5 years ]
  3. Proportion of abnormal vital signs [ Time Frame: Baseline and every 3 months for up to 5 years ]
  4. Propotion of abnormal electrocardiograms [ Time Frame: Baseline and final visit: up to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Successful completion of either Study RLM-MD-03 or Study RLM-MD-04
  • Ability to provide written 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 AE from a lead-in study, ie, a clinically significant finding on physical examination, clinical laboratory test, or 12-lead 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786380


Contacts
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Contact: Clinical Trials Registry Team 877‐277‐8566 IR‐CTRegistration@Allergan.com

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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Harvy Schneier Allergan

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03786380     History of Changes
Other Study ID Numbers: 3071-305-020
2019‐000406‐30 ( EudraCT Number )
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Allergan:
Diabetic Gastroparesis

Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms