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A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

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ClinicalTrials.gov Identifier: NCT03420781
Recruitment Status : Enrolling by invitation
First Posted : February 2, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastroparesis Diabetes Mellitus Drug: Relamorelin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 24, 2018
Estimated Primary Completion Date : December 6, 2020
Estimated Study Completion Date : December 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Relamorelin 10 μg
Relamorelin 10 μg injected subcutaneously twice daily for 46 weeks.
Drug: Relamorelin
Relamorelin 10 μg injected twice daily for 6, 40 or 46 weeks.

Experimental: Relamorelin 10 μg, followed by Placebo
Relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo injected twice daily for 6 weeks.
Drug: Relamorelin
Relamorelin 10 μg injected twice daily for 6, 40 or 46 weeks.

Drug: Placebo
Placebo injected twice daily for 6 weeks or 40 weeks.

Experimental: Placebo, followed by Relamorelin 10 μg
Placebo injected subcutaneously twice daily for 40 weeks, followed by Relamorelin 10 μg injected twice daily for 6 weeks.
Drug: Relamorelin
Relamorelin 10 μg injected twice daily for 6, 40 or 46 weeks.

Drug: Placebo
Placebo injected twice daily for 6 weeks or 40 weeks.




Primary Outcome Measures :
  1. Diabetic Gastroparesis Symptom Severity Score (DGSSS) Week-12 Responder [ Time Frame: Baseline to Week 12 ]
    Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.

  2. Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment [ Time Frame: Baseline to Week 12 ]
    Vomiting episodes will be patient-recorded daily using an electronic diary.


Secondary Outcome Measures :
  1. Nausea Week 12 Responder [ Time Frame: Baseline to Week 12 ]
    Nausea responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.

  2. Abdominal Pain Week 12 Responder [ Time Frame: Baseline to Week 12 ]
    Abdominal pain responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.

  3. Bloating Week 12 Responder [ Time Frame: Baseline to Week 12 ]
    Bloating responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.

  4. Postprandial Fullness Week 12 Responder [ Time Frame: Baseline to Week 12 ]

    Postprandial Fullness responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period.

    Postprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.


  5. DGSSS Week 40 Responder [ Time Frame: Baseline to Week 40 ]
    DGSSS responder defined as a participant who has at least a 10-point improvement in the DGSSS compared to baseline in each of the last 4 weeks of the 40-week Treatment Period.

  6. DGSSS at Week 40 [ Time Frame: Baseline to Week 40 ]
    Change from baseline to Week 40 in average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the four weeks prior to Week 40 (Visit 7) in this study.

  7. Vomiting Frequency at Week 40 [ Time Frame: Baseline to Week 40 ]
    Change from baseline to Week 40 in average weekly number of vomiting episodes derived as the average of the weekly number of vomiting episodes during the four weeks prior to Week 40 (Visit 7) in this study.

  8. Vomiting Week-40 Responder [ Time Frame: Baseline to Week 40 ]
    Vomiting responder defined as a participant with zero weekly vomiting episodes during each of the last 4 weeks of the 40-week Treatment Period.

  9. DGSSS at Week 46 [ Time Frame: Baseline to Week 46 ]
    Change from baseline (CFB) to end of Randomized withdrawl period (RWP) in the average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the six weeks of the RWP.

  10. Number of Vomiting Episodes at Week 46 [ Time Frame: Baseline to Week 46 ]
    CFB to end of RWP in the average weekly number of vomiting episodes. Average weekly scores are derived as the average of the weekly number of vomiting episodes from the six weeks of the RWP.

  11. Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE) [ Time Frame: Baseline to Week 46 ]
    The number of patients who experienced one or more TEAE during the 46 week treatment period.



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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:

  • 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

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): NCT03420781


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Sponsors and Collaborators
Allergan
Investigators
Study Director: Wieslaw (Wes) Bochenek, MD, PhD Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03420781     History of Changes
Other Study ID Numbers: RLM-MD-03
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

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

Keywords provided by Allergan:
diabetic gastroparesis
vomiting

Additional relevant MeSH terms:
Diabetes Mellitus
Gastroparesis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms