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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01880424




Registration number
NCT01880424
Ethics application status
Date submitted
12/06/2013
Date registered
19/06/2013
Date last updated
27/09/2016

Titles & IDs
Public title
A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Scientific title
A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Secondary ID [1] 0 0
ICP-103-307
Universal Trial Number (UTN)
Trial acronym
D5630C00001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome With Constipation (IBS-C) 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
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

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

Placebo comparator: controlled arm -

Experimental: treatment arm -


Treatment: Drugs: Placebo
matching Placebo Capsules, Oral, once daily

Treatment: Drugs: Linaclotide
Linaclotide 290 ug Capsules, Oral, once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
12-week Abdominal Pain/Abdominal Discomfort Weekly Responder
Timepoint [1] 0 0
Baseline and Weeks 1-12 during the Treatment Period
Primary outcome [2] 0 0
12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder
Timepoint [2] 0 0
Baseline and Weeks 1-12 during the Treatment Period
Secondary outcome [1] 0 0
Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate
Timepoint [1] 0 0
Baseline and 12-week Treatment Period
Secondary outcome [2] 0 0
Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate
Timepoint [2] 0 0
Baseline and 12-week Treatment Period
Secondary outcome [3] 0 0
Change From Baseline in 12-week Stool Consistency
Timepoint [3] 0 0
Baseline and 12-week Treatment Period
Secondary outcome [4] 0 0
Change From Baseline in 12-week Severity of Straining
Timepoint [4] 0 0
Baseline and 12-week Treatment Period
Secondary outcome [5] 0 0
Change From Baseline in 12-week Abdominal Bloating
Timepoint [5] 0 0
Baseline and 12-week Treatment Period
Secondary outcome [6] 0 0
Change From Baseline in 12-week Abdominal Pain
Timepoint [6] 0 0
Baseline and 12-week Treatment Period
Secondary outcome [7] 0 0
Change From Baseline in 12-week Abdominal Discomfort
Timepoint [7] 0 0
Baseline and 12-week Treatment Period

Eligibility
Key inclusion criteria
1. Patient has signed an Informed Consent Form(ICF).
2. Patient Must not be pregnant or breastfeeding and agree to use birth control
3. Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines and no clinically-significant laboratory or physical examination findings;
4. Patient meets protocol-defined criteria for Irritable Bowel Syndrome with Constipation(IBS-C), including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria
5. Patient meets protocol-defined eDiary completion Compliance and agrees to refrain from making any new, major life-style changes that may affect IBS-C symptoms
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Recent history of mushy or watery stools
2. Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study
3. Patient currently has both unexplained and clinically significant alarm symptoms or systemic signs of infection or colitis.
4. Surgery to the gastrointestinal tract
5. Usage of prohibited medications

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
1722
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Brisbane
Recruitment hospital [3] 0 0
Research Site - Five Dock
Recruitment hospital [4] 0 0
Research Site - Malvern
Recruitment hospital [5] 0 0
Research Site - Maroubra
Recruitment hospital [6] 0 0
Research Site - Melbourne
Recruitment hospital [7] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Five Dock
Recruitment postcode(s) [4] 0 0
- Malvern
Recruitment postcode(s) [5] 0 0
- Maroubra
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment postcode(s) [7] 0 0
- 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
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Montana
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
West Virginia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
China
State/province [23] 0 0
Beijing
Country [24] 0 0
China
State/province [24] 0 0
Changsha
Country [25] 0 0
China
State/province [25] 0 0
Chengdu
Country [26] 0 0
China
State/province [26] 0 0
Chongqing
Country [27] 0 0
China
State/province [27] 0 0
Guangzhou
Country [28] 0 0
China
State/province [28] 0 0
Hangzhou
Country [29] 0 0
China
State/province [29] 0 0
Harerbin
Country [30] 0 0
China
State/province [30] 0 0
Hefei
Country [31] 0 0
China
State/province [31] 0 0
Jinan
Country [32] 0 0
China
State/province [32] 0 0
Nanchang
Country [33] 0 0
China
State/province [33] 0 0
Qingdao
Country [34] 0 0
China
State/province [34] 0 0
Shanghai
Country [35] 0 0
China
State/province [35] 0 0
Shenyang
Country [36] 0 0
China
State/province [36] 0 0
Shijiazhuang
Country [37] 0 0
China
State/province [37] 0 0
Wuhan
Country [38] 0 0
China
State/province [38] 0 0
Xi An
Country [39] 0 0
China
State/province [39] 0 0
Xiamen
Country [40] 0 0
New Zealand
State/province [40] 0 0
Auckland
Country [41] 0 0
New Zealand
State/province [41] 0 0
Christchurch
Country [42] 0 0
New Zealand
State/province [42] 0 0
Dunedin
Country [43] 0 0
New Zealand
State/province [43] 0 0
Tauranga
Country [44] 0 0
New Zealand
State/province [44] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Ironwood Pharmaceuticals, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo. Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be randomized at up to 60 trial centers in China, Australia, and New Zealand.

The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12 weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment Period, patients meeting the entry criteria for this trial will be randomized to one of two double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).
Trial website
https://clinicaltrials.gov/study/NCT01880424
Trial related presentations / publications
Peng LH, Fang JY, Dai N, Shen XZ, Yang YL, Sun J, Yang YS. Efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation: Chinese sub-cohort analysis of a phase III, randomized, double-blind, placebo-controlled trial. J Dig Dis. 2022 Feb;23(2):99-110. doi: 10.1111/1751-2980.13081.
Public notes

Contacts
Principal investigator
Name 0 0
Yunsheng Yang
Address 0 0
Chinese PLA General Hospital
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01880424