Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03285308




Registration number
NCT03285308
Ethics application status
Date submitted
14/09/2017
Date registered
18/09/2017

Titles & IDs
Public title
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01
Scientific 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
Secondary ID [1] 0 0
2017-002136-16
Secondary ID [2] 0 0
RLM-MD-01
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 - Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.

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


Treatment: Drugs: Placebo
Placebo injected subcutaneously twice daily.

Treatment: Drugs: Relamorelin
Relamorelin 10 micrograms (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 (Day-14 to Day-1) to Week 12
Primary outcome [2] 0 0
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Timepoint [2] 0 0
Week 6 to Week 12
Secondary outcome [1] 0 0
Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Timepoint [1] 0 0
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Secondary outcome [2] 0 0
Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Timepoint [2] 0 0
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Secondary outcome [3] 0 0
Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Timepoint [3] 0 0
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Secondary outcome [4] 0 0
Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Timepoint [4] 0 0
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Secondary outcome [5] 0 0
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
Timepoint [5] 0 0
Up to approximately 16 weeks
Secondary outcome [6] 0 0
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Timepoint [6] 0 0
Up to 12 weeks
Secondary outcome [7] 0 0
Number of Participants With Clinically Meaningful Trends for Vital Signs
Timepoint [7] 0 0
Up to 12 weeks
Secondary outcome [8] 0 0
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Timepoint [8] 0 0
Up to 12 weeks
Secondary outcome [9] 0 0
Number of Participants With a =1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
Timepoint [9] 0 0
Baseline (Day 1) up to 12 weeks
Secondary outcome [10] 0 0
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
Timepoint [10] 0 0
Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84)

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

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 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
29/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/07/2020
Sample size
Target
Accrual to date
Final
336
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
The Alfred Hospital - Melbourne
Recruitment hospital [4] 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
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Iowa
Country [13] 0 0
United States of America
State/province [13] 0 0
Kansas
Country [14] 0 0
United States of America
State/province [14] 0 0
Kentucky
Country [15] 0 0
United States of America
State/province [15] 0 0
Louisiana
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Minnesota
Country [20] 0 0
United States of America
State/province [20] 0 0
Montana
Country [21] 0 0
United States of America
State/province [21] 0 0
Nevada
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oklahoma
Country [27] 0 0
United States of America
State/province [27] 0 0
Oregon
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
South Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Utah
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
West Virginia
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Ruse
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Plovdiv
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Sofia
Country [38] 0 0
France
State/province [38] 0 0
Nantes Cedex 1
Country [39] 0 0
France
State/province [39] 0 0
Rouen Cedex
Country [40] 0 0
India
State/province [40] 0 0
Andhra Pradesh
Country [41] 0 0
India
State/province [41] 0 0
Gujarat
Country [42] 0 0
India
State/province [42] 0 0
Karnataka
Country [43] 0 0
India
State/province [43] 0 0
Maharashtra
Country [44] 0 0
India
State/province [44] 0 0
Rajasthan
Country [45] 0 0
India
State/province [45] 0 0
Tamil Nadu
Country [46] 0 0
India
State/province [46] 0 0
Uttar Pradesh
Country [47] 0 0
India
State/province [47] 0 0
Madurai
Country [48] 0 0
India
State/province [48] 0 0
New Delhi
Country [49] 0 0
Israel
State/province [49] 0 0
Beer Sheba
Country [50] 0 0
Israel
State/province [50] 0 0
Haifa
Country [51] 0 0
Israel
State/province [51] 0 0
Holon
Country [52] 0 0
Israel
State/province [52] 0 0
Jerusalem
Country [53] 0 0
Israel
State/province [53] 0 0
Petach Tikva
Country [54] 0 0
Israel
State/province [54] 0 0
Safed
Country [55] 0 0
Israel
State/province [55] 0 0
Tel Aviv
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Jeollabuk-Do
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Nowon-gu
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Seoul
Country [59] 0 0
Malaysia
State/province [59] 0 0
Kedah
Country [60] 0 0
Malaysia
State/province [60] 0 0
Kuala Lumpur
Country [61] 0 0
Malaysia
State/province [61] 0 0
Kubang Kerian
Country [62] 0 0
Malaysia
State/province [62] 0 0
Taiping
Country [63] 0 0
Philippines
State/province [63] 0 0
Manila
Country [64] 0 0
Philippines
State/province [64] 0 0
Metro Manila
Country [65] 0 0
Philippines
State/province [65] 0 0
NCR
Country [66] 0 0
Philippines
State/province [66] 0 0
Cebu City
Country [67] 0 0
Philippines
State/province [67] 0 0
IloIlo City
Country [68] 0 0
Philippines
State/province [68] 0 0
Quezon City
Country [69] 0 0
Poland
State/province [69] 0 0
Gdansk
Country [70] 0 0
Poland
State/province [70] 0 0
Malopolska
Country [71] 0 0
Poland
State/province [71] 0 0
Mazowian
Country [72] 0 0
Poland
State/province [72] 0 0
Pomorskie
Country [73] 0 0
Poland
State/province [73] 0 0
Poznañ
Country [74] 0 0
Poland
State/province [74] 0 0
Warmia-Mazury
Country [75] 0 0
Poland
State/province [75] 0 0
Bialystok
Country [76] 0 0
Poland
State/province [76] 0 0
Chojnice
Country [77] 0 0
Poland
State/province [77] 0 0
Czestochowa
Country [78] 0 0
Poland
State/province [78] 0 0
Kraków
Country [79] 0 0
Poland
State/province [79] 0 0
Lodz
Country [80] 0 0
Poland
State/province [80] 0 0
Lublin
Country [81] 0 0
Poland
State/province [81] 0 0
Warszawa
Country [82] 0 0
Poland
State/province [82] 0 0
Wroclaw
Country [83] 0 0
Singapore
State/province [83] 0 0
Singapore
Country [84] 0 0
Spain
State/province [84] 0 0
Madrid
Country [85] 0 0
Spain
State/province [85] 0 0
Salamanca
Country [86] 0 0
Spain
State/province [86] 0 0
Sevilla
Country [87] 0 0
Thailand
State/province [87] 0 0
Bangkok
Country [88] 0 0
Thailand
State/province [88] 0 0
Chiang Mai
Country [89] 0 0
Ukraine
State/province [89] 0 0
Odesa Region
Country [90] 0 0
Ukraine
State/province [90] 0 0
Vinnyts'ka Oblast'
Country [91] 0 0
Ukraine
State/province [91] 0 0
Zaporizhzhia Region
Country [92] 0 0
Ukraine
State/province [92] 0 0
Chernivtsi
Country [93] 0 0
Ukraine
State/province [93] 0 0
Dnipro
Country [94] 0 0
Ukraine
State/province [94] 0 0
Ivano-Frankivsk
Country [95] 0 0
Ukraine
State/province [95] 0 0
Kharkiv
Country [96] 0 0
Ukraine
State/province [96] 0 0
Kherson
Country [97] 0 0
Ukraine
State/province [97] 0 0
Kyiv
Country [98] 0 0
Ukraine
State/province [98] 0 0
Odesa
Country [99] 0 0
Ukraine
State/province [99] 0 0
Poltava
Country [100] 0 0
Ukraine
State/province [100] 0 0
Ternopil
Country [101] 0 0
Ukraine
State/province [101] 0 0
Vinnytsia
Country [102] 0 0
Ukraine
State/province [102] 0 0
Zaporizhzhia

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
Wieslaw (Wes) Bochenek, MD, PhD
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT03285308