Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03383146
Recruitment Status : Active, not recruiting
First Posted : December 26, 2017
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE December 19, 2017
First Posted Date  ICMJE December 26, 2017
Last Update Posted Date May 15, 2020
Actual Study Start Date  ICMJE February 1, 2018
Estimated Primary Completion Date July 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
  • 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
  • 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
  • Number of participants with adverse events (AEs) [ Time Frame: Baseline to Week 52 ]
    Incidence of AEs
  • 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
  • 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
  • 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
  • ECG PR Interval [ Time Frame: Baseline to Week 52 ]
    The number of participants who experienced CS ECG values during the 52 week treatment period
  • ECG QRS Interval [ Time Frame: Baseline to Week 52 ]
    The number of participants who experienced CS ECG values during the 52 week treatment period
  • ECG QT Interval [ Time Frame: Baseline to Week 52 ]
    The number of participants who experienced CS ECG values during the 52 week treatment period
  • ECG QTc Interval [ Time Frame: Baseline to Week 52 ]
    The number of participants who experienced CS ECG values during the 52 week treatment period
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 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 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.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 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 52 ]
    The number of patients who experienced one or more TEAE during the 52 week treatment period.
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 Study 04
Official Title  ICMJE A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
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.
Detailed Description Active, not recruiting due to COVID-19
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastroparesis
  • Diabetes Mellitus
Intervention  ICMJE
  • Drug: Relamorelin
    Relamorelin 10 μg injected twice daily for 52 weeks.
  • Drug: Placebo
    Placebo injected twice daily for 2 weeks or 52 weeks.
Study Arms  ICMJE
  • Experimental: Relamorelin 10 μg
    Relamorelin 10 μg injected subcutaneously twice daily for 52 weeks.
    Intervention: Drug: Relamorelin
  • Placebo Comparator: Placebo
    Placebo injected twice daily for 52 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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 19, 2017)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 29, 2021
Estimated Primary Completion Date July 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Colombia,   Denmark,   France,   Germany,   Hungary,   India,   Israel,   Korea, Republic of,   Latvia,   Malaysia,   Mexico,   Philippines,   Poland,   Romania,   Russian Federation,   Singapore,   South Africa,   Spain,   Thailand,   Ukraine,   United Kingdom,   United States
Removed Location Countries Italy,   Saudi Arabia
 
Administrative Information
NCT Number  ICMJE NCT03383146
Other Study ID Numbers  ICMJE RLM-MD-04
2017-002144-33 ( 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 Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Harvy Schneier Allergan
PRS Account Allergan
Verification Date May 2020

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