12-Week Study of Plecanatide for CIC (The National CIC3 Study)
The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.
Chronic Idiopathic Constipation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A National, Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients With Chronic Idiopathic Constipation|
- Proportion of patients who are overall responders [ Time Frame: 12-week Treatment Period ] [ Designated as safety issue: No ]
The study's primary efficacy endpoint is the proportion of patients who are overall responders for the 12-week Treatment Period.
An overall responder is defined as a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks. A weekly responder is defined as a patient who has ≥ 3 Complete Spontaneous Bowel Movements (CSBMs) per week and an increase from baseline of ≥1 CSBM for that week. A CSBM is a bowel movement that occurs in the absence of laxative use within 24 hours and is associated with the feeling of complete evacuation.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Plecanatide 3.0 mg
Plecanatide tablets 3.0 mg QD for 12 weeks
Experimental: Plecanatide 6.0 mg
Plecanatide tablets 6.0 mg QD for 12 weeks
Placebo Comparator: Placebo
Matching placebo tablets QD for 12 weeks
This is a national, randomized, 12-week, double-blind, placebo-controlled, study in approximately 1350 adult male and female patients with CIC comparing 2 doses of plecanatide to placebo. The study will be conducted at approximately 180 clinical study sites in the United States. The primary objective of the study is to evaluate the efficacy and safety of 3.0 and 6.0 mg of plecanatide administered once daily (QD) for 12 weeks in a population of patients with CIC. The study population will include only patients without other causes of constipation or other chronic conditions that could interfere with study assessments. Patients may not take laxatives (with the exception of the study-provided rescue medication, bisacodyl 5mg tablets), or a number of prohibited drugs that are known to cause constipation or diarrhea, during study participation.
There are 6 scheduled study visits, including the screening and follow-up visits. The planned duration of participation in this study will be 112 days and up to 155 days, with washout and all visit windows considered.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02122471
Show 172 Study Locations
|Study Director:||Mary Beth Layton||Synergy Pharmaceuticals Inc.|