Clinical trial NCT01880424: 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)
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Ironwood Pharmaceuticals, Inc.
First posted: 2013-06-19
Enrollment: 1722
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

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

Primary outcomes:
measure: 12-week Abdominal Pain/Abdominal Discomfort Weekly Responder
timeFrame: Baseline and Weeks 1-12 during the Treatment Period
measure: 12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder
timeFrame: Baseline and Weeks 1-12 during the Treatment Period
Secondary outcomes:
measure: Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate
timeFrame: Baseline and 12-week Treatment Period
measure: Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate
timeFrame: Baseline and 12-week Treatment Period
measure: Change From Baseline in 12-week Stool Consistency
timeFrame: Baseline and 12-week Treatment Period
measure: Change From Baseline in 12-week Severity of Straining
timeFrame: Baseline and 12-week Treatment Period
measure: Change From Baseline in 12-week Abdominal Bloating
timeFrame: Baseline and 12-week Treatment Period
measure: Change From Baseline in 12-week Abdominal Pain
timeFrame: Baseline and 12-week Treatment Period
measure: Change From Baseline in 12-week Abdominal Discomfort
timeFrame: Baseline and 12-week Treatment Period
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: North Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Phoenix
country: United States
facility: Research Site
state: Arkansas
city: Artesia
country: United States
facility: Research Site
state: California
city: Chula Vista
country: United States
facility: Research Site
state: California
city: Encino
country: United States
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state: California
city: North Hollywood
country: United States
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state: California
city: Orange
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state: California
city: Riverside
country: United States
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city: San Diego
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state: Florida
city: Brandon
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city: Doral
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city: Lauderdale Lakes
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city: Miami Lakes
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city: Evansville
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city: Crowley
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city: Monroe
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city: Shreveport
country: United States
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state: Louisiana
city: Boston
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city: Chesterfield
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city: Wyoming
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city: Las Vegas
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city: Brooklyn
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state: New York
city: Great Neck
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city: New York
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state: New York
city: Raleigh
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state: North Carolina
city: Salisbury
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city: Winston-Salem
country: United States
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state: North Carolina
city: Cincinnati
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state: Ohio
city: Dayton
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state: Ohio
city: Franklin
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city: Mentor
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state: Ohio
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state: South Carolina
city: Chattanooga
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state: Tennessee
city: Kingsport
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state: Tennessee
city: Knoxville
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state: Tennessee
city: Smyrna
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state: Tennessee
city: Houston
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Webster
country: United States
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state: Texas
city: Ogden
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state: Utah
city: Lynchburg
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state: Virginia
city: Morgantown
country: United States
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state: West Virginia
city: Adelaide
country: Australia
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city: Brisbane
country: Australia
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city: Five Dock
country: Australia
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city: Malvern
country: Australia
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city: Maroubra
country: Australia
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city: Melbourne
country: Australia
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city: Parkville
country: Australia
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city: Vaughan
country: Canada
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state: Ontario
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
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city: Chengdu
country: China
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city: Chongqing
country: China
facility: Research Site
city: Guangzhou
country: China
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city: Hangzhou
country: China
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city: Harerbin
country: China
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city: Hefei
country: China
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city: Jinan
country: China
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city: Nanchang
country: China
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city: Qingdao
country: China
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city: Shanghai
country: China
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city: Shenyang
country: China
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city: Shijiazhuang
country: China
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city: Wuhan
country: China
facility: Research Site
city: Xi An
country: China
facility: Research Site
city: Xiamen
country: China
facility: Research Site
city: Auckland
country: New Zealand
facility: Research Site
city: Christchurch
country: New Zealand
facility: Research Site
city: Dunedin
country: New Zealand
facility: Research Site
city: Tauranga
country: New Zealand
facility: Research Site
city: Wellington
country: New Zealand
facility: Research Site
Study officials:
affiliation: Chinese PLA General Hospital
name: Yunsheng Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Friendship Hospital
name: Shutian Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Changhai Hospital Affiliated to Second Military Mecical University of Chinese PLA
name: Zhaoshen Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Changzheng Hospital Affiliated to Second Military Mecical University of Chinese PLA
name: Weifen Xie
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University
name: Yaozong Yuan
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Youqing Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Affiliated Hospital of Third Military Mecical University of Chinese PLA
name: Dongfeng Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital, Zhongshan (Sun Yat-sen) University
name: Minhu Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Qilu Hospital of Shandong University
name: Yanqing Li
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital of Shenyang Military Region of Chinese PLA
name: Xiaozhong Guo
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Harbin Medical University
name: Youlin Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Third Military Mecical University of Chinese PLA
name: Rongquan Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Union Hospital of Tongji Medical College of Huazhong University of Science & Technology
name: Xiaohua Hou
role: PRINCIPAL_INVESTIGATOR
affiliation: Sichuang Provincial People's Hospital
name: Liangping Li
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Chengwei Tang
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Hospital Affiliated to Xiamen University
name: Jianlin Ren
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Zhongshan Hospital
name: Xizhong Shen
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University People's Hospital
name: Yulan Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tongren Hospital Affiliated to Capital Medical University
name: Dongmei Qian
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University First Hospital
name: Huahong Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.