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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03420781




Registration number
NCT03420781
Ethics application status
Date submitted
24/01/2018
Date registered
1/02/2018
Date last updated
10/12/2018

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
Metabolic and Endocrine 0 0 0 0
Diabetes
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 - Relamorelin
Treatment: Drugs - Placebo

Experimental: Relamorelin 10 µg - Relamorelin 10 µg injected subcutaneously twice daily for 46 weeks.

Experimental: Relamorelin 10 µg, followed by Placebo - Relamorelin 10 µg injected subcutaneously twice daily for 40 weeks, followed by placebo injected twice daily for 6 weeks.

Experimental: Placebo, followed by Relamorelin 10 µg - Placebo injected subcutaneously twice daily for 40 weeks, followed by Relamorelin 10 µg injected twice daily for 6 weeks.


Treatment: Drugs: Relamorelin
Relamorelin 10 µg injected twice daily for 6, 40 or 46 weeks.

Treatment: Drugs: Placebo
Placebo injected twice daily for 6 weeks or 40 weeks.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diabetic Gastroparesis Symptom Severity Score (DGSSS) Week-12 Responder - Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.
Timepoint [1] 0 0
Baseline to Week 12
Primary outcome [2] 0 0
Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment - Vomiting episodes will be patient-recorded daily using an electronic diary.
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Nausea Week 12 Responder - Nausea responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [2] 0 0
Abdominal Pain Week 12 Responder - Abdominal pain responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [3] 0 0
Bloating Week 12 Responder - Bloating responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.
Timepoint [3] 0 0
Baseline to Week 12
Secondary outcome [4] 0 0
Postprandial Fullness Week 12 Responder - Postprandial Fullness responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period.
Postprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.
Timepoint [4] 0 0
Baseline to Week 12
Secondary outcome [5] 0 0
DGSSS Week 40 Responder - DGSSS responder defined as a participant who has at least a 10-point improvement in the DGSSS compared to baseline in each of the last 4 weeks of the 40-week Treatment Period.
Timepoint [5] 0 0
Baseline to Week 40
Secondary outcome [6] 0 0
DGSSS at Week 40 - Change from baseline to Week 40 in average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the four weeks prior to Week 40 (Visit 7) in this study.
Timepoint [6] 0 0
Baseline to Week 40
Secondary outcome [7] 0 0
Vomiting Frequency at Week 40 - Change from baseline to Week 40 in average weekly number of vomiting episodes derived as the average of the weekly number of vomiting episodes during the four weeks prior to Week 40 (Visit 7) in this study.
Timepoint [7] 0 0
Baseline to Week 40
Secondary outcome [8] 0 0
Vomiting Week-40 Responder - Vomiting responder defined as a participant with zero weekly vomiting episodes during each of the last 4 weeks of the 40-week Treatment Period.
Timepoint [8] 0 0
Baseline to Week 40
Secondary outcome [9] 0 0
DGSSS at Week 46 - Change from baseline (CFB) to end of Randomized withdrawl period (RWP) in the average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the six weeks of the RWP.
Timepoint [9] 0 0
Baseline to Week 46
Secondary outcome [10] 0 0
Number of Vomiting Episodes at Week 46 - CFB to end of RWP in the average weekly number of vomiting episodes. Average weekly scores are derived as the average of the weekly number of vomiting episodes from the six weeks of the RWP.
Timepoint [10] 0 0
Baseline to Week 46
Secondary outcome [11] 0 0
Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE) - The number of patients who experienced one or more TEAE during the 46 week treatment period.
Timepoint [11] 0 0
Baseline to Week 46

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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
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Giessen
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Heves
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Jász-Nagykun-Szolnok
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Zala
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India
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Rajasthan
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Tamil Nadu
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India
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Uttar Prandesh
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West Bengal
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India
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Israel
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Israel
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Tel Aviv
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Bari
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Italy
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Genova
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Napoli
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Italy
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Pavia
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Italy
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Pisa
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Italy
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Rome
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Salerno
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Italy
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San Giovanni Rotondo
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Mexico
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Mexico DF
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Tlalpan
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NCR
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Katowice
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Warszawa
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Wroclaw
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Oltenia
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Romania
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Bucharest
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Romania
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Russian Federation
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Leningrad Region
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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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Saratov
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Singapore
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Singapore
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Gauteng
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Cape Town
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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
A 46-week study to compare the efficacy of relamorelin with that of placebo in participants
with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants
will either continue on relamorelin or placebo for 6 additional weeks.
Trial website
https://clinicaltrials.gov/show/NCT03420781
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

No data has been provided for results reporting
Summary results
Not applicable