Trial Review

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/NCT03420781




Registration number
NCT03420781
Ethics application status
Date submitted
24/01/2018
Date registered
5/02/2018
Date last updated
22/12/2021

Titles & IDs
Public title
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03
Scientific title
A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
Secondary ID [1] 0 0
RLM-MD-03
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: Treatment Period: Placebo - Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.

Experimental: Treatment Period: Relamorelin 10 µg - Relamorelin 10 micrograms (µg) injected subcutaneously twice daily for up to 40 weeks.

Experimental: Randomized Withdrawal Period: Placebo then Relamorelin 10 µg - Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 µg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period.

Experimental: Randomized Withdrawal Period: Relamorelin 10 µg then Relamorelin 10 µg - Participants who received relamorelin 10 µg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.

Experimental: Randomized Withdrawal Period: Relamorelin 10 µg then Placebo - Participants who received relamorelin 10 µg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.


Treatment: Drugs: Placebo
Placebo injected twice daily

Treatment: Drugs: Relamorelin
Relamorelin 10 µg injected 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) of the Treatment Period
Timepoint [1] 0 0
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study
Primary outcome [2] 0 0
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the 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 First 12-weeks of the Treatment Period
Timepoint [1] 0 0
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) 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 First 12-weeks of the Treatment Period
Timepoint [2] 0 0
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) 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 First 12-weeks of the Treatment Period
Timepoint [3] 0 0
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) 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 First 12-weeks of the Treatment Period
Timepoint [4] 0 0
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Secondary outcome [5] 0 0
Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period
Timepoint [5] 0 0
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
Secondary outcome [6] 0 0
Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period
Timepoint [6] 0 0
Week 37 to Week 40
Secondary outcome [7] 0 0
Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period
Timepoint [7] 0 0
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
Secondary outcome [8] 0 0
Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period
Timepoint [8] 0 0
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)
Secondary outcome [9] 0 0
Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period
Timepoint [9] 0 0
Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)
Secondary outcome [10] 0 0
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
Timepoint [10] 0 0
First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks)
Secondary outcome [11] 0 0
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Timepoint [11] 0 0
Up to 46 weeks
Secondary outcome [12] 0 0
Number of Participants With Clinically Meaningful Trends for Vital Signs
Timepoint [12] 0 0
Up to 46 weeks
Secondary outcome [13] 0 0
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Timepoint [13] 0 0
Up to 46 weeks
Secondary outcome [14] 0 0
Number of Participants With a =1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
Timepoint [14] 0 0
Up to 46 weeks
Secondary outcome [15] 0 0
Number of Participants With Anti-relamorelin Antibody Testing Results
Timepoint [15] 0 0
Up to 46 weeks

Eligibility
Key inclusion criteria
* Participants are eligible to be included in the study only if all the following criteria apply:
* Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study
* Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
* In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants are excluded from the study if any of the following criteria apply:
* Participant is not willing or able to abide by the restrictions regarding concomitant medicine use
* Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03
* Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study
* Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease

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
24/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/10/2020
Sample size
Target
Accrual to date
Final
467
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 - 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
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
Idaho
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Iowa
Country [14] 0 0
United States of America
State/province [14] 0 0
Kansas
Country [15] 0 0
United States of America
State/province [15] 0 0
Kentucky
Country [16] 0 0
United States of America
State/province [16] 0 0
Louisiana
Country [17] 0 0
United States of America
State/province [17] 0 0
Maryland
Country [18] 0 0
United States of America
State/province [18] 0 0
Massachusetts
Country [19] 0 0
United States of America
State/province [19] 0 0
Michigan
Country [20] 0 0
United States of America
State/province [20] 0 0
Minnesota
Country [21] 0 0
United States of America
State/province [21] 0 0
Montana
Country [22] 0 0
United States of America
State/province [22] 0 0
Nebraska
Country [23] 0 0
United States of America
State/province [23] 0 0
Nevada
Country [24] 0 0
United States of America
State/province [24] 0 0
New Jersey
Country [25] 0 0
United States of America
State/province [25] 0 0
New Mexico
Country [26] 0 0
United States of America
State/province [26] 0 0
New York
Country [27] 0 0
United States of America
State/province [27] 0 0
North Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
Ohio
Country [29] 0 0
United States of America
State/province [29] 0 0
Oklahoma
Country [30] 0 0
United States of America
State/province [30] 0 0
Oregon
Country [31] 0 0
United States of America
State/province [31] 0 0
Pennsylvania
Country [32] 0 0
United States of America
State/province [32] 0 0
South Carolina
Country [33] 0 0
United States of America
State/province [33] 0 0
South Dakota
Country [34] 0 0
United States of America
State/province [34] 0 0
Tennessee
Country [35] 0 0
United States of America
State/province [35] 0 0
Texas
Country [36] 0 0
United States of America
State/province [36] 0 0
Utah
Country [37] 0 0
United States of America
State/province [37] 0 0
Virginia
Country [38] 0 0
United States of America
State/province [38] 0 0
Washington
Country [39] 0 0
United States of America
State/province [39] 0 0
West Virginia
Country [40] 0 0
Argentina
State/province [40] 0 0
Buenos Aires Province
Country [41] 0 0
Argentina
State/province [41] 0 0
Cordoba
Country [42] 0 0
Argentina
State/province [42] 0 0
Santa Fe
Country [43] 0 0
Argentina
State/province [43] 0 0
Tucuman
Country [44] 0 0
Argentina
State/province [44] 0 0
Ciudad Autonoma de Buenos Aires
Country [45] 0 0
Argentina
State/province [45] 0 0
Corrientes
Country [46] 0 0
Austria
State/province [46] 0 0
Styria
Country [47] 0 0
Austria
State/province [47] 0 0
Vorarlberg
Country [48] 0 0
Austria
State/province [48] 0 0
Salzburg
Country [49] 0 0
Austria
State/province [49] 0 0
Steyr
Country [50] 0 0
Belgium
State/province [50] 0 0
Antwerp
Country [51] 0 0
Belgium
State/province [51] 0 0
Brussel
Country [52] 0 0
Belgium
State/province [52] 0 0
West-Vlaanderen
Country [53] 0 0
Brazil
State/province [53] 0 0
Ceara
Country [54] 0 0
Brazil
State/province [54] 0 0
Ceará
Country [55] 0 0
Brazil
State/province [55] 0 0
Distrito Federal
Country [56] 0 0
Brazil
State/province [56] 0 0
Rio Grande Do Sul
Country [57] 0 0
Brazil
State/province [57] 0 0
Santa Catarina
Country [58] 0 0
Brazil
State/province [58] 0 0
Sao Paulo
Country [59] 0 0
Brazil
State/province [59] 0 0
São Paulo
Country [60] 0 0
Brazil
State/province [60] 0 0
Belém
Country [61] 0 0
Bulgaria
State/province [61] 0 0
Ruse
Country [62] 0 0
Bulgaria
State/province [62] 0 0
Plovdiv
Country [63] 0 0
Canada
State/province [63] 0 0
Alberta
Country [64] 0 0
Canada
State/province [64] 0 0
British Columbia
Country [65] 0 0
Canada
State/province [65] 0 0
Nova Scotia
Country [66] 0 0
Canada
State/province [66] 0 0
Ontario
Country [67] 0 0
Canada
State/province [67] 0 0
Quebec
Country [68] 0 0
Colombia
State/province [68] 0 0
Antioquia
Country [69] 0 0
Colombia
State/province [69] 0 0
Atlantico
Country [70] 0 0
Colombia
State/province [70] 0 0
Cundinamarca
Country [71] 0 0
Colombia
State/province [71] 0 0
Distrito Capital De Bogota
Country [72] 0 0
Colombia
State/province [72] 0 0
Distrito Capital De Bogotá
Country [73] 0 0
Colombia
State/province [73] 0 0
Risaralda
Country [74] 0 0
Colombia
State/province [74] 0 0
Valle Del Cauca
Country [75] 0 0
Denmark
State/province [75] 0 0
Copenhagen
Country [76] 0 0
Germany
State/province [76] 0 0
Baden-Wuertemberg
Country [77] 0 0
Germany
State/province [77] 0 0
Saxony
Country [78] 0 0
Germany
State/province [78] 0 0
Hamburg
Country [79] 0 0
Germany
State/province [79] 0 0
Hannover
Country [80] 0 0
Hungary
State/province [80] 0 0
Csonfrád
Country [81] 0 0
Hungary
State/province [81] 0 0
Heves
Country [82] 0 0
Hungary
State/province [82] 0 0
Jász-Nagykun-Szolnok
Country [83] 0 0
Hungary
State/province [83] 0 0
Zala
Country [84] 0 0
Hungary
State/province [84] 0 0
Budapest
Country [85] 0 0
India
State/province [85] 0 0
Andhra Pradesh
Country [86] 0 0
India
State/province [86] 0 0
Gujarat
Country [87] 0 0
India
State/province [87] 0 0
Karnataka
Country [88] 0 0
India
State/province [88] 0 0
Maharashtra
Country [89] 0 0
India
State/province [89] 0 0
Rajasthan
Country [90] 0 0
India
State/province [90] 0 0
Tamil Nadu
Country [91] 0 0
India
State/province [91] 0 0
Uttar Prandesh
Country [92] 0 0
India
State/province [92] 0 0
New Delhi
Country [93] 0 0
Israel
State/province [93] 0 0
Haifa
Country [94] 0 0
Israel
State/province [94] 0 0
Safed
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Jeollabuk-Do
Country [96] 0 0
Korea, Republic of
State/province [96] 0 0
Nowon-gu
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Seoul
Country [98] 0 0
Latvia
State/province [98] 0 0
Kraslavas Nov.
Country [99] 0 0
Latvia
State/province [99] 0 0
Daugavpils
Country [100] 0 0
Latvia
State/province [100] 0 0
Riga
Country [101] 0 0
Malaysia
State/province [101] 0 0
Kedah
Country [102] 0 0
Malaysia
State/province [102] 0 0
Kubang Kerian
Country [103] 0 0
Malaysia
State/province [103] 0 0
Taiping
Country [104] 0 0
Mexico
State/province [104] 0 0
Cdmx
Country [105] 0 0
Mexico
State/province [105] 0 0
Distrito Federal
Country [106] 0 0
Mexico
State/province [106] 0 0
Guillermina
Country [107] 0 0
Mexico
State/province [107] 0 0
Jalisco
Country [108] 0 0
Mexico
State/province [108] 0 0
Mexico DF
Country [109] 0 0
Mexico
State/province [109] 0 0
Yucatán
Country [110] 0 0
Mexico
State/province [110] 0 0
Aguascalientes
Country [111] 0 0
Mexico
State/province [111] 0 0
Durango
Country [112] 0 0
Mexico
State/province [112] 0 0
Veracruz
Country [113] 0 0
Philippines
State/province [113] 0 0
IloIlo
Country [114] 0 0
Philippines
State/province [114] 0 0
Metro Manila
Country [115] 0 0
Philippines
State/province [115] 0 0
Metropolitan Manila
Country [116] 0 0
Philippines
State/province [116] 0 0
NCR
Country [117] 0 0
Philippines
State/province [117] 0 0
Cebu City
Country [118] 0 0
Poland
State/province [118] 0 0
Podlaski
Country [119] 0 0
Poland
State/province [119] 0 0
Pomorskie
Country [120] 0 0
Poland
State/province [120] 0 0
Chojnice
Country [121] 0 0
Poland
State/province [121] 0 0
Krakow
Country [122] 0 0
Poland
State/province [122] 0 0
Wroclaw
Country [123] 0 0
Russian Federation
State/province [123] 0 0
Leningrad Region
Country [124] 0 0
Russian Federation
State/province [124] 0 0
Novosibirskaya Oblast
Country [125] 0 0
Russian Federation
State/province [125] 0 0
Sankt-Peterburg
Country [126] 0 0
Russian Federation
State/province [126] 0 0
Volga
Country [127] 0 0
Russian Federation
State/province [127] 0 0
Kazan
Country [128] 0 0
Russian Federation
State/province [128] 0 0
Moscow
Country [129] 0 0
Russian Federation
State/province [129] 0 0
Rostov on Don
Country [130] 0 0
Russian Federation
State/province [130] 0 0
Rostov-on-Don
Country [131] 0 0
Russian Federation
State/province [131] 0 0
Saratov
Country [132] 0 0
Singapore
State/province [132] 0 0
Singapore
Country [133] 0 0
South Africa
State/province [133] 0 0
Free State
Country [134] 0 0
South Africa
State/province [134] 0 0
Gauteng
Country [135] 0 0
South Africa
State/province [135] 0 0
Western Cape
Country [136] 0 0
Thailand
State/province [136] 0 0
Bangkok
Country [137] 0 0
Thailand
State/province [137] 0 0
Chiang Mai
Country [138] 0 0
Ukraine
State/province [138] 0 0
Ivano-Frankivsk Oblast
Country [139] 0 0
Ukraine
State/province [139] 0 0
Chernivtsi
Country [140] 0 0
Ukraine
State/province [140] 0 0
Dnipro
Country [141] 0 0
Ukraine
State/province [141] 0 0
Kharkiv
Country [142] 0 0
Ukraine
State/province [142] 0 0
Kherson
Country [143] 0 0
Ukraine
State/province [143] 0 0
Kyiv
Country [144] 0 0
Ukraine
State/province [144] 0 0
Odesa
Country [145] 0 0
Ukraine
State/province [145] 0 0
Poltava
Country [146] 0 0
Ukraine
State/province [146] 0 0
Ternopil
Country [147] 0 0
Ukraine
State/province [147] 0 0
Vinnytsia
Country [148] 0 0
Ukraine
State/province [148] 0 0
Zaporizhzhia
Country [149] 0 0
United Kingdom
State/province [149] 0 0
East Midland
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Greater Manchester
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Lancashire
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Staffordshire
Country [153] 0 0
United Kingdom
State/province [153] 0 0
West Yorkshire
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Barnsley
Country [155] 0 0
United Kingdom
State/province [155] 0 0
Blackpool
Country [156] 0 0
United Kingdom
State/province [156] 0 0
Chelmsford
Country [157] 0 0
United Kingdom
State/province [157] 0 0
Liverpool
Country [158] 0 0
United Kingdom
State/province [158] 0 0
Stockton-on-Tees

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 Bochenek
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/NCT03420781