Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
Status: | Completed |
---|---|
Conditions: | Constipation |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | October 2014 |
End Date: | August 2015 |
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide (72 ug or 145 ug) Administered Orally for 12 Weeks to Patients With Chronic Idiopathic Constipation
The objective of this trial is to determine the efficacy and safety of linaclotide
administered to patients with chronic idiopathic constipation (CIC). The primary efficacy
parameter is the percentage of patients in each dosing group that meet the protocol
definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder.
administered to patients with chronic idiopathic constipation (CIC). The primary efficacy
parameter is the percentage of patients in each dosing group that meet the protocol
definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder.
Inclusion Criteria:
- Patient has completed a colonoscopy if one is needed according to the AGA criteria,
with no clinically significant findings
- Patient has no clinically significant findings on a physical examination and clinical
laboratory tests
- Patient meets protocol criteria for CIC: reports < 3 bowel movements per week and
reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard
stools, sensation of incomplete evacuation
- Patient demonstrates continued chronic idiopathic constipation through Pretreatment
Period
- Patient is compliant with daily IVRS (interactive voice response system) calls
Exclusion Criteria:
- Patient has history of loose or watery stools
- Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)
- Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease
or condition that can affect GI motility
- Patient has any protocol-excluded or clinically significant medical or surgical
history that could confound the study assessments
We found this trial at
107
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials