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Trial record 21 of 43 for:    Recruiting, Not yet recruiting, Available Studies | "Gastroparesis"

Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis Study 02

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ClinicalTrials.gov Identifier: NCT03426345
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : January 18, 2020
Estimated Study Completion Date : January 18, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Relamorelin 10μg
Relamorelin 10μg injected subcutaneously twice daily for 12 weeks.
Drug: Relamorelin
Relamorelin 10μg injected twice daily for 12 weeks.

Placebo Comparator: Placebo
Placebo injected twice daily for 12 weeks.
Drug: Placebo
Placebo injected twice daily for 12 weeks




Primary Outcome Measures :
  1. 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 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. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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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:

  • 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
  • History of an eating disorder (eg, anorexia nervosa, binge-eating, bulimia) in the past 5 years
  • Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
  • History of gastrointestinal disorders that may be similar to gasteroparisis
  • Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus

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): NCT03426345


Contacts
Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@allergan.com

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

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03426345     History of Changes
Other Study ID Numbers: RLM-MD-02
2017-002177-20 ( EudraCT Number )
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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