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Therapeutic Areas: Gastroenterology
Disease Category: Irritable Bowel Syndrome (IBS)

Trial Information

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients with Irritable Bowel Syndrome with Constipation.

This study is for men or women who are 18 years of age or older. This trial will consist of up to 21 days of screening, 14 to 21 days of pretreatment, and 12 weeks of double-blind treatment. Subjects will be randomly assigned into one of the following treatment groups: 300 mg Linaclotide (study drug) or placebo. Total patient participation is expected to last up to 22 weeks. There are 9 office visits and subjects will be reimbursed between $40 and $50 per completed visit. In the event that a colonoscopy is needed for screening, the subject will be reimbursed an additional $50 for having that procedure completed.

Patient Inclusion Criteria:

• Male or female aged 18 years or older
• Reports experiencing less than 3 bowel movements a week
• Reports abdominal discomfort or pain that has two or more of the following three features for at least 12 weeks, which need not be consecutive, in the 12 months before Visit 1:
  • Relieved with defecation
  • Onset associated with a change in frequency of stool
  • Onset associated with a change in form (appearance) of stool
• Is willing to discontinue use of any laxatives before Visit 2 in favor of the Rescue Medicine (Dulcolax) which will be provided, if necessary

Patient Exclusion Criteria:

• Has Active Peptic Ulcer Disease
• Has Parkinson's Disease, a Spinal Cord Injury or Multiple Sclerosis
• Has history of Bariatric surgery
• Has history of Diabetic Neuropathy
• Has history of Celiac Sprue
• Has history of Fecal Impaction that required hospitalization
• Has history of Diverticulitis or any chronic condition associated with abdominal pain or discomfort (e.g., Chronic Pancreatitis, Polycystic Kidney Disease, Ovarian Cysts, Endometriosis, Lactose Intolerance

Cheryl Nickles, Patient Recruitment Coordinator
Chase Medical Research, LLC
500 Chase Parkway, 3rd Floor
Waterbury, CT 06708
Phone: (203) 419-4404
Fax: (203) 465-7924
EMail: cnickles@chasemr.com

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