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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
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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
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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State/province [20] 0 0
Minnesota
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Montana
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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West Virginia
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Argentina
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Cordoba
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Santa Fe
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Tucuman
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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Corrientes
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Styria
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Vorarlberg
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Salzburg
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Steyr
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Ceará
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Sao Paulo
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Ruse
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Plovdiv
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Alberta
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Distrito Capital De Bogotá
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Saxony
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Hannover
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Csonfrád
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Heves
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Zala
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Andhra Pradesh
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India
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Gujarat
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India
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Karnataka
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India
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Maharashtra
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India
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Rajasthan
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India
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Tamil Nadu
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India
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Uttar Prandesh
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India
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Haifa
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Israel
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Safed
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Korea, Republic of
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Jeollabuk-Do
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Korea, Republic of
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Nowon-gu
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Korea, Republic of
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Seoul
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Latvia
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Kraslavas Nov.
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Latvia
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Kedah
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Cdmx
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Guillermina
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Jalisco
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Mexico
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Mexico DF
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Aguascalientes
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Mexico
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NCR
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Chojnice
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Krakow
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Wroclaw
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Russian Federation
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Leningrad Region
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Russian Federation
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Novosibirskaya Oblast
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Volga
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Rostov on Don
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Russian Federation
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Rostov-on-Don
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Russian Federation
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Saratov
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Free State
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Gauteng
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South Africa
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Western Cape
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Ukraine
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Ivano-Frankivsk Oblast
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Ukraine
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Chernivtsi
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Ukraine
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Dnipro
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Ukraine
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Kharkiv
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Ukraine
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Kherson
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Ukraine
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Kyiv
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Ukraine
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Odesa
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Ukraine
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Poltava
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Ukraine
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Ternopil
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhzhia
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United Kingdom
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East Midland
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United Kingdom
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Greater Manchester
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United Kingdom
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Lancashire
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United Kingdom
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Staffordshire
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United Kingdom
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West Yorkshire
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United Kingdom
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Barnsley
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United Kingdom
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Blackpool
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United Kingdom
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Chelmsford
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United Kingdom
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Liverpool
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United Kingdom
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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