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A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04

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ClinicalTrials.gov Identifier: NCT03383146
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.

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: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 52-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 : December 19, 2017
Estimated Primary Completion Date : September 28, 2020
Estimated Study Completion Date : September 28, 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 52 weeks.
Drug: Relamorelin
Relamorelin 10 μg injected twice daily for 52 weeks.

Placebo Comparator: Placebo
Placebo injected twice daily for 52 weeks.
Drug: Placebo
Placebo injected twice daily for 2 weeks or 52 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 52 ]
    The number of patients who experienced one or more TEAE during the 52 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:

  • Two different groups of participants may enter into the study:
  • Participants must meet all the inclusion criteria at screening (Visit 1) and at the end of the Run-in Period (Visit 3) for randomization into the Treatment Period of RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) (including compliance with dosing,entry of diary data into the DGSSD during the lead-in study Run-in Period) during the lead-in study Run-in Period at the end of the lead-in study Run-in Period, are eligible for randomization in Study RLM-MD-04 if:
  • 1) They had no vomiting episodes recorded in the DGSSD and had an average daily DGSSS ≥ 12 at the end of the lead-in study Run-in Period.

OR

  • 2) They had vomiting episodes recorded in the DGSSD but had an average daily DGSSS of ≥ 12 and < 16 at the end of the lead-in study Run-in Period.

In the current study, these "rollover participants" will enter the study at Visit 1 (Randomization); they will not undergo Screening (Visit -2) or the Run-in Visit (Visit -1) procedures

Patients who undergo screening and run-in procedures in Study RLM-MD-04 are "de novo participants". To be eligible for randomization in the current study, de novo participants must meet all Screening and Run-in Period criteria for Study RLM-MD-04, including:

  1. At Screening, be male or female age 18 years and older, with BMI > 18.5 kg/m2; T1DM or T2DM with controlled and stable blood glucose levels and HbA1c ≤ 11%; symptoms suggestive of DG for at least 3 months (one of which must be nausea), with mechanical obstruction of the GI tract as the cause of symptoms having been ruled out; delayed GE by gastric emptying breath test (GEBT).
  2. After Run-in Period: Evidence of compliance during the Run-in Period with the use of the electronic hand-held device for entry of data, with twice daily SC injections of the study treatment, and no treatment with GI promotility agents; a score of ≥ 12 for the average of the daily DGSSS measured during the Run-in Period.

Exclusion Criteria:

  • There are no exclusion criteria specific to this study; participants will be excluded from this study if any of the exclusion criteria apply at screening (Visit 1) and at the end of the Run-in Period (Visit 3) for randomization into the Treatment Period of studies RLM-MD-01 and RLM-MD-02, except as specified in the inclusion criteria

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): NCT03383146


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: NCT03383146     History of Changes
Other Study ID Numbers: RLM-MD-04
2017-002144-33 ( EudraCT Number )
First Posted: December 26, 2017    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