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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03383146




Registration number
NCT03383146
Ethics application status
Date submitted
19/12/2017
Date registered
26/12/2017
Date last updated
23/11/2021

Titles & IDs
Public title
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04
Scientific 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
Secondary ID [1] 0 0
2017-002144-33
Secondary ID [2] 0 0
RLM-MD-04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroparesis 0 0
Diabetes Mellitus 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Relamorelin

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.

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.


Treatment: Drugs: Placebo
Placebo injected subcutaneously twice daily.

Treatment: Drugs: Relamorelin
Relamorelin 10 µg injected subcutaneously twice daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Change From Baseline to Week 52 in the Weekly Average DGSSS
Timepoint [2] 0 0
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
Primary outcome [3] 0 0
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
Timepoint [3] 0 0
First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks)
Primary outcome [4] 0 0
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Timepoint [4] 0 0
Up to 52 weeks
Primary outcome [5] 0 0
Number of Participants With Clinically Meaningful Trends for Vital Signs
Timepoint [5] 0 0
Up to 52 weeks
Primary outcome [6] 0 0
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Timepoint [6] 0 0
Up to 52 weeks
Primary outcome [7] 0 0
Number of Participants With a =1% Increase in Glycosylated Hemoglobin A1c (HbA1c)
Timepoint [7] 0 0
Up to 52 weeks
Primary outcome [8] 0 0
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
Timepoint [8] 0 0
Baseline (Day 1), Day 84, Day 364, and End of Treatment (Up to Day 364)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/11/2020
Sample size
Target
Accrual to date
Final
450
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated - Adelaide
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Kharkiv
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Kherson
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Greater Manchester
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Blackpool
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Chelmsford
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Harvy Schneier
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03383146