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)

Irritable Bowel Syndrome With Constipation (IBS-C) Clinical Trial

— D5630C00001  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880424
• Other study ID #: ICP-103-307
• Status: Completed
• Phase: Phase 3
• First received: June 12, 2013
• Last updated: May 26, 2015
• Start date: July 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationAustralia: Therapeutic Goods Administration (TGA)New Zealand: Ministry of Health, Medsafe
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1722
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Constipation (IBS-C)
• Syndrome

Intervention

Drug:
• Placebo
matching Placebo Capsules, Oral, once daily
• Linaclotide
Linaclotide 290 ug Capsules, Oral, once daily

Locations

Country	Name	City	State
Australia	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
Canada	Research Site	Vaughan	Ontario
China	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
New Zealand	Research Site	Auckland
New Zealand	Research Site	Christchurch
New Zealand	Research Site	Dunedin
New Zealand	Research Site	Tauranga
New Zealand	Research Site	Wellington
United States	Research Site	Addison	Illinois
United States	Research Site	Artesia	California
United States	Research Site	Billings	Montana
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boynton Beach	Florida
United States	Research Site	Brandon	Florida
United States	Research Site	Brooklyn	New York
United States	Research Site	Brooksville	Florida
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Chesterfield	Michigan
United States	Research Site	Chula Vista	California
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Crowley	Louisiana
United States	Research Site	Dayton	Ohio
United States	Research Site	Doral	Florida
United States	Research Site	Encino	California
United States	Research Site	Evansville	Indiana
United States	Research Site	Franklin	Ohio
United States	Research Site	Gainesville	Florida
United States	Research Site	Great Neck	New York
United States	Research Site	Greer	South Carolina
United States	Research Site	Hialeah	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Huntsville	Alabama
United States	Research Site	Kingsport	Tennessee
United States	Research Site	Kissimmee	Florida
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lauderdale Lakes	Florida
United States	Research Site	Lynchburg	Virginia
United States	Research Site	Mentor	Ohio
United States	Research Site	Miami	Florida
United States	Research Site	Miami Lakes	Florida
United States	Research Site	Monroe	Louisiana
United States	Research Site	Morgantown	West Virginia
United States	Research Site	New York	New York
United States	Research Site	North Hollywood	California
United States	Research Site	North Little Rock	Arkansas
United States	Research Site	Ogden	Utah
United States	Research Site	Orange	California
United States	Research Site	Phoenix	Arkansas
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Riverside	California
United States	Research Site	Salisbury	North Carolina
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Smyrna	Tennessee
United States	Research Site	St. Louis	Missouri
United States	Research Site	Webster	Texas
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Wyoming	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Ironwood Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal Pain/Abdominal Discomfort Weekly Responder rate	A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria for at least 6 out of the first 12 weeks of the Treatment Period.	12 weeks	No
Primary	Irritable Bowel Syndrome (IBS) Degree of Relief Responder rate	A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria for at least 6 out of the 12 weeks of the Treatment Period.	12weeks	No
Secondary	Change from Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate		12weeks	No
Secondary	Change from Baseline in 12-week Spontaneous Bowel Movement Frequency Rate		12weeks	No
Secondary	Change from Baseline in 12-week Stool Consistency		12weeks	No
Secondary	Change from Baseline in 12-week Severity of Straining		12 weeks	No
Secondary	Change from Baseline in 12-week Abdominal Bloating		12 weeks	No
Secondary	Change from Baseline in 12-week Abdominal Pain		12 weeks	No
Secondary	Change from Baseline in 12-week Abdominal Discomfort		12 weeks	No