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)

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).

Conditions

• Irritable Bowel Syndrome With Constipation (IBS-C)

Interventions

DRUG

Placebo

matching Placebo Capsules, Oral, once daily

DRUG

Linaclotide

Linaclotide 290 ug Capsules, Oral, once daily

Sponsors & Collaborators

• Ironwood Pharmaceuticals, Inc.

  collaborator INDUSTRY

• AstraZeneca

  lead INDUSTRY

Principal Investigators

• Yunsheng Yang · Chinese PLA General Hospital

• Shutian Zhang · Beijing Friendship Hospital

• Zhaoshen Li · Changhai Hospital Affiliated to Second Military Mecical University of Chinese PLA

• Weifen Xie · Changzheng Hospital Affiliated to Second Military Mecical University of Chinese PLA

• Yaozong Yuan · Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University

• Youqing Xu · Beijing Tiantan Hospital

• Dongfeng Chen · The Third Affiliated Hospital of Third Military Mecical University of Chinese PLA

• Minhu Chen · The First Affiliated Hospital, Zhongshan (Sun Yat-sen) University

• Yanqing Li · Qilu Hospital of Shandong University

• Xiaozhong Guo · General Hospital of Shenyang Military Region of Chinese PLA

• Youlin Yang · First Affiliated Hospital of Harbin Medical University

• Rongquan Wang · The First Affiliated Hospital of Third Military Mecical University of Chinese PLA

• Xiaohua Hou · Union Hospital of Tongji Medical College of Huazhong University of Science & Technology

• Liangping Li · Sichuang Provincial People's Hospital

• Chengwei Tang · West China Hospital

• Jianlin Ren · Zhongshan Hospital Affiliated to Xiamen University

• Xizhong Shen · Shanghai Zhongshan Hospital

• Yulan Liu · Peking University People's Hospital

• Dongmei Qian · Beijing Tongren Hospital Affiliated to Capital Medical University

• Huahong Wang · Peking University First Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-31

Primary Completion

2015-05-31

Completion

2015-05-31

Countries

• United States
• Australia
• Canada
• China
• New Zealand

Study Locations