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Trial record 1 of 1 for:    NCT03285308
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A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis

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ClinicalTrials.gov Identifier: NCT03285308
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE September 14, 2017
First Posted Date  ICMJE September 18, 2017
Last Update Posted Date June 11, 2019
Actual Study Start Date  ICMJE September 29, 2017
Estimated Primary Completion Date November 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Percentage of patients meeting the diabetic gastroparesis symptom responder criterion during the 12 weeks of treatment [ Time Frame: Baseline, 12 Weeks ]
    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.
  • Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment [ Time Frame: 12 Weeks ]
    Vomiting episodes will be patient-recorded daily using an electronic diary.
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
Percentage of patients meeting the diabetic gastroparesis symptom responder criterion in each of the last 6 of the 12 weeks of treatment [ Time Frame: Baseline, 12 Weeks ]
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.
Change History Complete list of historical versions of study NCT03285308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
  • Percentage of Patients Meeting the Nausea Responder Criterion [ Time Frame: Baseline to Week 12 ]
    A Nausea Responder is defined as an improvement of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the 12-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.
  • Percentage of Patients Meeting the Abdominal Pain Responder Criterion [ Time Frame: Baseline to Week 12 ]
    An Abdominal Pain Responder is defined as an improvement of at least 2-points in the weekly symptom scores for Abdominal Pain at each of the last 6 weeks of the 12-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.
  • Percentage of Patients Meeting the Bloating Responder Criterion [ Time Frame: Baseline to Week 12 ]
    A Bloating Responder is defined as an improvement of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the 12-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.
  • Percentage of Patients Meeting the Postprandial Fullness Responder Criterion [ Time Frame: Baseline to Week 12 ]
    A Postprandial Fullness Responder is defined as an improvement of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the 12-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
  • Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE) [ Time Frame: Baseline to Week 12 ]
    The number of patients who experienced one or more TEAE during the 12 week treatment period.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment [ Time Frame: 12 Weeks ]
Vomiting episodes will be patient-recorded daily using an electronic diary.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis
Official Title  ICMJE A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
Brief Summary This study will evaluate the safety and efficacy of Relamorelin compared to placebo in patients with diabetic gastroparesis. Patients will report daily severity scores of their diabetic gastroparesis symptoms.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastroparesis
  • Diabetes Mellitus
Intervention  ICMJE
  • Drug: Relamorelin
    Relamorelin 10 μg injected twice daily for 12 weeks.
  • Drug: Placebo
    Placebo injected twice daily for 2 weeks or 12 weeks.
Study Arms  ICMJE
  • Experimental: Relamorelin 10 μg
    Relamorelin 10 μg injected subcutaneously twice daily for 12 weeks.
    Intervention: Drug: Relamorelin
  • Placebo Comparator: Placebo
    Placebo injected twice daily for 12 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2017)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 23, 2019
Estimated Primary Completion Date November 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Registry Team 877‐277‐8566 IR-CTRegistration@allergan.com
Listed Location Countries  ICMJE Australia,   Bulgaria,   France,   India,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Philippines,   Poland,   Saudi Arabia,   Singapore,   Spain,   Thailand,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03285308
Other Study ID Numbers  ICMJE RLM-MD-01
2017-002136-16 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wieslaw (Wes) Bochenek, MD, PhD Allergan
PRS Account Allergan
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP