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

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ClinicalTrials.gov Identifier: NCT03426345
Recruitment Status : Terminated (The Relamorelin program is being terminated solely based on a business decision)
First Posted : February 8, 2018
Results First Posted : August 6, 2021
Last Update Posted : August 6, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 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 16, 2018
Actual Primary Completion Date : July 16, 2020
Actual Study Completion Date : July 16, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
Drug: Placebo
Placebo injected subcutaneously twice daily.

Experimental: Relamorelin 10 μg
Following a 2-week placebo run-in, participants received relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 12 weeks.
Drug: Relamorelin
Relamorelin 10 μg injected twice daily for 12 weeks.




Primary Outcome Measures :
  1. Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) [ Time Frame: Baseline (Day-14 to Day-1) to Week 12 ]
    Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0= no or not at all uncomfortable to 10= worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period.

  2. Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [ Time Frame: Week 6 to Week 12 ]
    The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the 12-week Treatment Period.


Secondary Outcome Measures :
  1. Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [ Time Frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12) ]
    A Nausea Responder was defined as a participant with improvement (decrease) 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 was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0= no nausea to 10= worst possible nausea.

  2. Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [ Time Frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12) ]
    An Abdominal Pain Responder was defined as a participant with an improvement (decrease) 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 was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0= no abdominal pain to 10= the worst possible abdominal pain and was recorded in an e-diary.

  3. Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [ Time Frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12) ]
    A Bloating Responder was defined as a participant with an improvement (decrease) 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 was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0= no bloating and 10= the worst possible bloating and was recorded in the e-diary.

  4. Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [ Time Frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12) ]
    A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) 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 was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0= no feeling of fullness until finishing a meal (best) to 10= feeling full after only a few bites (worst).

  5. Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) [ Time Frame: Up to approximately 16 weeks ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.

  6. Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results [ Time Frame: Up to 12 weeks ]
    Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

  7. Number of Participants With Clinically Meaningful Trends for Vital Signs [ Time Frame: Up to 12 weeks ]
    Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.

  8. Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results [ Time Frame: Up to 12 weeks ]
    A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.

  9. Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) [ Time Frame: Baseline (Day 1) up to 12 weeks ]
  10. Number of Participants With Anti-relamorelin Antibody Testing Results by Visit [ Time Frame: Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84) ]
    A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.



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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
  • 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

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


Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Wieslaw (Wes) Bochenek, MD, PhD Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] March 5, 2019
Statistical Analysis Plan  [PDF] November 17, 2020

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03426345    
Other Study ID Numbers: RLM-MD-02
2017-002177-20 ( EudraCT Number )
First Posted: February 8, 2018    Key Record Dates
Results First Posted: August 6, 2021
Last Update Posted: August 6, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations