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Trial record 2 of 2 for:    RLM-MD-04 | United States

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 : Terminated (The Relamorelin program is being terminated solely based on a business decision.)
First Posted : December 26, 2017
Results First Posted : November 23, 2021
Last Update Posted : November 23, 2021
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: Placebo Drug: Relamorelin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 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 : February 1, 2018
Actual Primary Completion Date : November 5, 2020
Actual Study Completion Date : November 5, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Drug: Placebo
Placebo injected subcutaneously twice daily.

Experimental: Relamorelin 10 μg
Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Drug: Relamorelin
Relamorelin 10 μg injected subcutaneously twice daily.




Primary Outcome Measures :
  1. Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) [ Time Frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 12 of this study ]
    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 of the previous study or the run-in period of this study for new participants.

  2. Change From Baseline to Week 52 in the Weekly Average DGSSS [ Time Frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 52 of this study ]
    Participants assessed the severity of diabetic gastroparesis symptoms daily using the 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). The average weekly scores at Week 52 were the average of the DGSSS scores from Week 49 to Week 52. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.

  3. Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) [ Time Frame: First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 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.

  4. Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results [ Time Frame: Up to 52 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 participant had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

  5. Number of Participants With Clinically Meaningful Trends for Vital Signs [ Time Frame: Up to 52 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.

  6. Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results [ Time Frame: Up to 52 weeks ]
    A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.

  7. Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c) [ Time Frame: Up to 52 weeks ]
  8. Number of Participants With Anti-relamorelin Antibody Testing Results by Visit [ Time Frame: Baseline (Day 1), Day 84, Day 364, and End of Treatment (Up to Day 364) ]
    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.



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:

  1. Rollover Participants

    Participants who were not randomization-eligible at the end of the Run-in Period of lead-in studies RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) are eligible to be randomized in the study if all of the following criteria apply:

    •In the lead-in studies, participants must have met all screening visit and Run-in Period criteria for randomization into the Treatment Period (including compliance with dosing, entry of diary data into the Diabetic Gastroparesis Symptom Severity Diary (DGSSD)) except that:

    • They had zero vomiting episodes and an average daily Diabetic Gastroparesis Symptom Severity Score (DGSSS) of ≥12 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device; OR
    • They had vomiting episodes and an average daily DGSSS of ≥12 but <16 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device
  2. De Novo Participants

    • Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) of at least 5 years' duration, with controlled and stable blood glucose levels and hemoglobin A1c (HBA1c) ≤11%
    • DG defined as at least a 3-month history prior to Screening of symptoms (one of which must be nausea) on an ongoing basis that are suggestive of gastroparesis (GP) (e.g., nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety)
    • Compliance with the entry of data into the hand-held electronic device during the Run-in Period
    • Compliance with administration of subcutaneous (SC) twice daily injections during the Run-in Period
    • The average of the daily DGSSS from the 2-week, Run-in Period must be ≥12

Exclusion Criteria:

  1. Both Rollover and De Novo Participants

    •Participants with a known allergy or hypersensitivity to the study treatments and their excipients (i.e., mannitol or phenol)

  2. Rollover Participants

    •Participants will be excluded from this study if any of the lead-in study exclusion criteria apply at the Screening Visit and at the end of the Run-in Period for randomization into the Treatment Period of studies RLM-MD-01 and RLM-MD-02, except as specified in the inclusion criteria

  3. De Novo Participants

    • History of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of the Screening Visit
    • History of intestinal malabsorption or pancreatic exocrine insufficiency
    • History of belching disorders, other nausea and vomiting disorders
    • Gastric or duodenal ulcer within 3 months of Screening
    • History of malignancy in the 3 years prior to Screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
    • Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression
    • Use of metoclopramide, domperidone, prucalopride, macrolide antibiotics (e.g., erythromycin, clarithromycin, azithromycin), or other drugs considered to be GI promotility agents for at least 10 days prior to the start of the Run-in Period
    • Currently taking opiates, or expecting to use opiates during the course of the clinical study
    • Treatment with glucagon-like peptide-1 (GLP-1) agonist for at least 6 weeks prior to the start of the Run-in Period
    • History of pyloric injection of botulinum toxin within 6 months of screening
    • History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure (a history of diagnostic endoscopy is not exclusionary)
    • Randomization in any previous study in which relamorelin was a treatment
    • Allergic to, or intolerant of egg, wheat, milk, or algae, as these are components of the gastric emptying breath test (GEBT) study meal

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


Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Harvy Schneier Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] February 12, 2021
Statistical Analysis Plan  [PDF] December 15, 2020

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03383146    
Other Study ID Numbers: RLM-MD-04
2017-002144-33 ( EudraCT Number )
First Posted: December 26, 2017    Key Record Dates
Results First Posted: November 23, 2021
Last Update Posted: November 23, 2021
Last Verified: November 2021

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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