The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C) (CIBS)
This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C.
Irritable Bowel Syndrome Characterized by Constipation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)|
- Change from baseline in the mean number of Complete Spontaneous Bowel Movement (CSBM) over the 12 week treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Proportion of patients who are overall responders during the 12 week Treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Abdominal pain intensity and stool frequency are co-endpoints for the responder analysis. A patient is categorized as a weekly responder on both pain intensity and stool frequency.
- Other secondary endpoints [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Change from baseline in Spontaneous Bowel Movement (SBM) frequency, stool consistency (BSFS), time to first SBM/CSBM, patient IVRS reported symptoms,and patient questionnaires ( QoL, Irritable Bowel Syndrome Severity Score (IBSSS), global severity, relief and treatment assessment) over the 12 week treatment period.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Plecanatide 0.3mg
Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks
Active Comparator: Plecanatide 1.0mg
Plecanatide 1.0mg one tablet by mouth daily for 12 weeks
Active Comparator: Plecanatide 3.0mg
Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks
Active Comparator: Plecanatide 9.0mg
Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks
Placebo Comparator: Placebo
Placebo, one tablet by mouth daily for 12 weeks
This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C. Patients will undergo a Screening Period to determine eligibility. After completing a Screening Visit patients will undergo a 2-week Pre-Treatment assessment using the Interactive Voice Response System (IVRS) during which they will complete daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale- BSFS), abdominal pain or abdominal discomfort and other symptoms associated with IBS-C. Data from the two-week IVRS Pre-treatment assessment are used to define the patient's baseline from which change will be determined. Patients who meet all entry criteria will be randomized to one of five treatment groups ( 0.3mg,1.0mg,3.0mg,9mg,or Placebo) on Day 1 of the Treatment Period. Patients will take an oral dose of study drug daily (QD) for 12 weeks and continue the daily IVRS diaries (BMs, abdominal pain, other symptoms). On Weeks 2, 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments. For 2 weeks after completing dosing, (i.e., Post-Treatment Period), patients will continue to complete daily IVRS diaries. Patients will then return to the clinical site for a final follow-up visit (End of Study Visit). The planned duration of participation in this study will be approximately 112 days from signing of informed consent through post-treatment or 145 days if 30 day washout of a prohibited concomitant medication or stabilization of a medical condition is required before Pre-Treatment (up to 148 days, with all windows considered).
|Contact: Laura Barrow, Pharm D||212 297 email@example.com|
Show 94 Study Locations
|Principal Investigator:||Philip B Miner, MD||Oklahoma Foundation for Digestive Research|