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)
D5630C00001
1 other identifier
interventional
1,722
5 countries
82
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2013
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2013
CompletedFirst Posted
Study publicly available on registry
June 19, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
September 27, 2016
CompletedSeptember 27, 2016
August 1, 2016
1.8 years
June 12, 2013
April 28, 2016
August 4, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
12-week Abdominal Pain/Abdominal Discomfort Weekly Responder
A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria (i.e., an improvement of ≥30% from baseline in either the mean abdominal pain score or mean abdominal discomfort score for that week, with neither score worsening from baseline for that week) for at least 6 out of the 12 weeks of the Treatment Period. Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point numerical rating scale (NRS) where 0 represents no abdominal pain and 10 represents very severe abdominal pain. Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort.
Baseline and Weeks 1-12 during the Treatment Period
12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder
A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria (i.e., response to the degree of relief of IBS symptoms question for that week was "Considerably relieved" or "Completely relieved") for at least 6 out of the 12 weeks of the Treatment Period. Degree of relief of IBS symptoms (in the last 7 days) was assessed weekly by patients on a 7-point balanced ordinal scale where 1 = Completely relieved, 4 = Unchanged, and 7 = As bad as I can imagine.
Baseline and Weeks 1-12 during the Treatment Period
Secondary Outcomes (7)
Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate
Baseline and 12-week Treatment Period
Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate
Baseline and 12-week Treatment Period
Change From Baseline in 12-week Stool Consistency
Baseline and 12-week Treatment Period
Change From Baseline in 12-week Severity of Straining
Baseline and 12-week Treatment Period
Change From Baseline in 12-week Abdominal Bloating
Baseline and 12-week Treatment Period
- +2 more secondary outcomes
Study Arms (2)
controlled arm
PLACEBO COMPARATORtreatment arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patient has signed an Informed Consent Form(ICF).
- Patient Must not be pregnant or breastfeeding and agree to use birth control
- Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines and no clinically-significant laboratory or physical examination findings;
- 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
- 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
You may not qualify if:
- Recent history of mushy or watery stools
- Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study
- Patient currently has both unexplained and clinically significant alarm symptoms or systemic signs of infection or colitis.
- Surgery to the gastrointestinal tract
- Usage of prohibited medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Ironwood Pharmaceuticals, Inc.collaborator
Study Sites (82)
Research Site
Huntsville, Alabama, United States
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North Little Rock, Arkansas, United States
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Phoenix, Arkansas, United States
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Artesia, California, United States
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Chula Vista, California, United States
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Encino, California, United States
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North Hollywood, California, United States
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Orange, California, United States
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Riverside, California, United States
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San Diego, California, United States
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Boynton Beach, Florida, United States
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Brandon, Florida, United States
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Brooksville, Florida, United States
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Doral, Florida, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
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Kissimmee, Florida, United States
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Lauderdale Lakes, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Addison, Illinois, United States
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Evansville, Indiana, United States
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Crowley, Louisiana, United States
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Monroe, Louisiana, United States
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Shreveport, Louisiana, United States
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Boston, Massachusetts, United States
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Chesterfield, Michigan, United States
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Wyoming, Michigan, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Las Vegas, Nevada, United States
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Brooklyn, New York, United States
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Great Neck, New York, United States
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New York, New York, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Franklin, Ohio, United States
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Mentor, Ohio, United States
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Greer, South Carolina, United States
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Chattanooga, Tennessee, United States
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Kingsport, Tennessee, United States
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Knoxville, Tennessee, United States
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Smyrna, Tennessee, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Webster, Texas, United States
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Ogden, Utah, United States
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Lynchburg, Virginia, United States
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Morgantown, West Virginia, United States
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Adelaide, Australia
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Brisbane, Australia
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Five Dock, Australia
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Malvern, Australia
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Maroubra, Australia
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Melbourne, Australia
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Parkville, Australia
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Vaughan, Ontario, Canada
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Beijing, China
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Changsha, China
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Chengdu, China
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Chongqing, China
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Guangzhou, China
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Hangzhou, China
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Harerbin, China
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Hefei, China
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Jinan, China
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Nanchang, China
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Qingdao, China
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Shanghai, China
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Shenyang, China
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Shijiazhuang, China
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Wuhan, China
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Xi'an, China
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Xiamen, China
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Auckland, New Zealand
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Christchurch, New Zealand
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Dunedin, New Zealand
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Tauranga, New Zealand
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Wellington, New Zealand
Related Publications (1)
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.
PMID: 35019221DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Peter Zeng
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Yunsheng Yang
Chinese PLA General Hospital
- PRINCIPAL INVESTIGATOR
Shutian Zhang
Beijing Friendship Hospital
- PRINCIPAL INVESTIGATOR
Zhaoshen Li
Changhai Hospital Affiliated to Second Military Mecical University of Chinese PLA
- PRINCIPAL INVESTIGATOR
Weifen Xie
Changzheng Hospital Affiliated to Second Military Mecical University of Chinese PLA
- PRINCIPAL INVESTIGATOR
Yaozong Yuan
Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University
- PRINCIPAL INVESTIGATOR
Youqing Xu
Beijing Tiantan Hospital
- PRINCIPAL INVESTIGATOR
Dongfeng Chen
The Third Affiliated Hospital of Third Military Mecical University of Chinese PLA
- PRINCIPAL INVESTIGATOR
Minhu Chen
The First Affiliated Hospital, Zhongshan (Sun Yat-sen) University
- PRINCIPAL INVESTIGATOR
Yanqing Li
Qilu Hospital of Shandong University
- PRINCIPAL INVESTIGATOR
Xiaozhong Guo
General Hospital of Shenyang Military Region of Chinese PLA
- PRINCIPAL INVESTIGATOR
Youlin Yang
First Affiliated Hospital of Harbin Medical University
- PRINCIPAL INVESTIGATOR
Rongquan Wang
The First Affiliated Hospital of Third Military Mecical University of Chinese PLA
- PRINCIPAL INVESTIGATOR
Xiaohua Hou
Union Hospital of Tongji Medical College of Huazhong University of Science & Technology
- PRINCIPAL INVESTIGATOR
Liangping Li
Sichuang Provincial People's Hospital
- PRINCIPAL INVESTIGATOR
Chengwei Tang
West China Hospital
- PRINCIPAL INVESTIGATOR
Jianlin Ren
Zhongshan Hospital Affiliated to Xiamen University
- PRINCIPAL INVESTIGATOR
Xizhong Shen
Shanghai Zhongshan Hospital
- PRINCIPAL INVESTIGATOR
Yulan Liu
Peking University People's Hospital
- PRINCIPAL INVESTIGATOR
Dongmei Qian
Beijing Tongren Hospital Affiliated to Capital Medical University
- PRINCIPAL INVESTIGATOR
Huahong Wang
Peking University First Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2013
First Posted
June 19, 2013
Study Start
July 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
September 27, 2016
Results First Posted
September 27, 2016
Record last verified: 2016-08