Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating
Status: | Completed |
---|---|
Conditions: | Constipation |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | Any |
Updated: | 2/4/2013 |
Start Date: | August 2012 |
End Date: | September 2013 |
Contact: | Sandra Beaird, PhD |
Email: | info@forestpharm.com |
Phone: | 1-800-678-1605 |
Phase 3b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Chronic Constipation and Prominent Abdominal Bloating at Baseline
The purpose of this study is to evaluate the efficacy and safety of linaclotide compared
with placebo in patients with chronic constipation (CC) and prominent abdominal bloating.
This study includes an up to 3-week screening period and a 2-3 week pretreatment period.
Patients who are eligible will be randomized to one of two doses of linaclotide or placebo
for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement
frequency, as well as other abdominal and bowel symptoms of CC.
Inclusion Criteria:
- Patient has completed a colonoscopy according to the American Gastroenterological
Association criteria with no clinically significant findings
- Patient has successfully completed protocol procedures (with no clinically
significant findings)
- Patient meets protocol criteria for Chronic Constipation(CC): < 3 bowel movements per
week and reports one or more of the following symptoms for at least 12 weeks:
1. Straining during more than 25% of BMs
2. Lumpy or hard stools during more than 25% of BMs
3. Sensation of incomplete evacuation during more than 25% of BMs
- Patient demonstrates continued chronic constipation and bloating through Pretreatment
Period
- Patient is compliant with Interactive voice response System (IVRS)
Exclusion Criteria:
- Patient has a 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 would limit the patient's ability to complete or participate in this
clinical trial or could confound the study assessments
We found this trial at
140
sites
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