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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 : November 1, 2019
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

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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 : July 28, 2021
Estimated Study Completion Date : July 28, 2021

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. Change from Baseline to Week 12 in the weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) [ Time Frame: Baseline to Week 12 ]
    Participants 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 using an electronic diary

  2. Change from Baseline to Week 52 in weekly average DGSSS [ Time Frame: Baseline to Week 52 ]
    Participants 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 using an electronic diary

  3. Number of participants with adverse events (AEs) [ Time Frame: Baseline to Week 52 ]
    Incidence of AEs

  4. Number of clinically significant (CS) clinical laboratory values [ Time Frame: Baseline to Week 52 ]
    The number of participants who experienced CS clinical laboratory values during the 52 week treatment period

  5. Vital sign values (heart rate, blood pressure, respiratory rate, and temperature) [ Time Frame: Baseline to Week 52 ]
    The number of participants who experienced CS vital sign values during the 52 week treatment period

  6. Electrocardiogram (ECG) Heart Rate [ Time Frame: Baseline to Week 52 ]
    The number of participants who experienced CS ECG values during the 52 week treatment period

  7. ECG PR Interval [ Time Frame: Baseline to Week 52 ]
    The number of participants who experienced CS ECG values during the 52 week treatment period

  8. ECG QRS Interval [ Time Frame: Baseline to Week 52 ]
    The number of participants who experienced CS ECG values during the 52 week treatment period

  9. ECG QT Interval [ Time Frame: Baseline to Week 52 ]
    The number of participants who experienced CS ECG values during the 52 week treatment period

  10. ECG QTc Interval [ Time Frame: Baseline to Week 52 ]
    The number of participants who experienced CS ECG values during the 52 week treatment period

  11. Change from Baseline in hemoglobin A1c (HbA1c) levels [ Time Frame: Baseline to Week 52 ]
    The number of participants who experienced CS HbA1c levels during the 52 week treatment period

  12. Change from Baseline in anti-relamorelin antibodies [ Time Frame: Baseline to Week 52 ]
    The number of participants who experienced anti-relamorelin antibodies during the 52 week treatment period



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:

  • 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). Participants are eligible for randomization into 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, 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;
  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, delayed GE by gastric emptying breath test (GEBT).

Exclusion Criteria:

  • Participants with a know allergy or hypersensitivity to the study treatments and their excipients (i.e., mannitol or phenol)
  • Rollover participants will be excluded from this study if any of the lead-in study exclusion criteria apply at Screening and at the end of the Run-in Period for randomization into the Treatment Period of 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): NCT03383146


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

Additional Information:
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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: November 1, 2019
Last Verified: October 2019

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