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)
NCT ID: NCT01880424
Last Updated: 2016-09-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1722 participants
INTERVENTIONAL
2013-07-31
2015-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation
NCT00948818
Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT00460811
A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT03573908
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT00938717
A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation
NCT02559817
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
controlled arm
Placebo
matching Placebo Capsules, Oral, once daily
treatment arm
Linaclotide
Linaclotide 290 ug Capsules, Oral, once daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
matching Placebo Capsules, Oral, once daily
Linaclotide
Linaclotide 290 ug Capsules, Oral, once daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ironwood Pharmaceuticals, Inc.
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yunsheng Yang
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Shutian Zhang
Role: PRINCIPAL_INVESTIGATOR
Beijing Friendship Hospital
Zhaoshen Li
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital Affiliated to Second Military Mecical University of Chinese PLA
Weifen Xie
Role: PRINCIPAL_INVESTIGATOR
Changzheng Hospital Affiliated to Second Military Mecical University of Chinese PLA
Yaozong Yuan
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University
Youqing Xu
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Dongfeng Chen
Role: PRINCIPAL_INVESTIGATOR
The Third Affiliated Hospital of Third Military Mecical University of Chinese PLA
Minhu Chen
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital, Zhongshan (Sun Yat-sen) University
Yanqing Li
Role: PRINCIPAL_INVESTIGATOR
Qilu Hospital of Shandong University
Xiaozhong Guo
Role: PRINCIPAL_INVESTIGATOR
General Hospital of Shenyang Military Region of Chinese PLA
Youlin Yang
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Harbin Medical University
Rongquan Wang
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Third Military Mecical University of Chinese PLA
Xiaohua Hou
Role: PRINCIPAL_INVESTIGATOR
Union Hospital of Tongji Medical College of Huazhong University of Science & Technology
Liangping Li
Role: PRINCIPAL_INVESTIGATOR
Sichuang Provincial People's Hospital
Chengwei Tang
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Jianlin Ren
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Hospital Affiliated to Xiamen University
Xizhong Shen
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Yulan Liu
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Dongmei Qian
Role: PRINCIPAL_INVESTIGATOR
Beijing Tongren Hospital Affiliated to Capital Medical University
Huahong Wang
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Huntsville, Alabama, United States
Research Site
North Little Rock, Arkansas, United States
Research Site
Phoenix, Arkansas, United States
Research Site
Artesia, California, United States
Research Site
Chula Vista, California, United States
Research Site
Encino, California, United States
Research Site
North Hollywood, California, United States
Research Site
Orange, California, United States
Research Site
Riverside, California, United States
Research Site
San Diego, California, United States
Research Site
Boynton Beach, Florida, United States
Research Site
Brandon, Florida, United States
Research Site
Brooksville, Florida, United States
Research Site
Doral, Florida, United States
Research Site
Gainesville, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Kissimmee, Florida, United States
Research Site
Lauderdale Lakes, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami Lakes, Florida, United States
Research Site
Addison, Illinois, United States
Research Site
Evansville, Indiana, United States
Research Site
Crowley, Louisiana, United States
Research Site
Monroe, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Boston, Massachusetts, United States
Research Site
Chesterfield, Michigan, United States
Research Site
Wyoming, Michigan, United States
Research Site
St Louis, Missouri, United States
Research Site
Billings, Montana, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Brooklyn, New York, United States
Research Site
Great Neck, New York, United States
Research Site
New York, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Salisbury, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Franklin, Ohio, United States
Research Site
Mentor, Ohio, United States
Research Site
Greer, South Carolina, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Kingsport, Tennessee, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Smyrna, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Webster, Texas, United States
Research Site
Ogden, Utah, United States
Research Site
Lynchburg, Virginia, United States
Research Site
Morgantown, West Virginia, United States
Research Site
Adelaide, , Australia
Research Site
Brisbane, , Australia
Research Site
Five Dock, , Australia
Research Site
Malvern, , Australia
Research Site
Maroubra, , Australia
Research Site
Melbourne, , Australia
Research Site
Parkville, , Australia
Research Site
Vaughan, Ontario, Canada
Research Site
Beijing, , China
Research Site
Changsha, , China
Research Site
Chengdu, , China
Research Site
Chongqing, , China
Research Site
Guangzhou, , China
Research Site
Hangzhou, , China
Research Site
Harerbin, , China
Research Site
Hefei, , China
Research Site
Jinan, , China
Research Site
Nanchang, , China
Research Site
Qingdao, , China
Research Site
Shanghai, , China
Research Site
Shenyang, , China
Research Site
Shijiazhuang, , China
Research Site
Wuhan, , China
Research Site
Xi'an, , China
Research Site
Xiamen, , China
Research Site
Auckland, , New Zealand
Research Site
Christchurch, , New Zealand
Research Site
Dunedin, , New Zealand
Research Site
Tauranga, , New Zealand
Research Site
Wellington, , New Zealand
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ICP-103-307
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.