Status:
COMPLETED
Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation
Lead Sponsor:
Ironwood Pharmaceuticals, Inc.
Conditions:
Chronic Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.
Eligibility Criteria
Inclusion
- Patient is 18 years of age or older
- Patient meets colonoscopy requirements according to the American Gastroenterological Association
- Patient meets criteria for chronic constipation including weekly bowel movement frequency requirements and reports one or more symptoms of constipation according to protocol requirements
- Patient has successfully completed study requirements with no clinically-significant findings: physical exam, ECG, clinical laboratory tests
- Patient is fluent in English
Exclusion
- Patient reports loose or watery stools
- Patient meets criteria for IBS including protocol-defined abdominal discomfort or pain
- Patient may not take prohibited medications per protocol
- Medical diagnoses, medical conditions, or family history that would not make the patient a good candidate for the study or limit the patient's ability to complete the clinical study
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT00402337
Start Date
November 1 2006
End Date
February 1 2008
Last Update
March 5 2013
Active Locations (60)
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1
Microbia Investigational Site
Huntsville, Alabama, United States, 35801
2
Microbia Investigational Site
Tucson, Arizona, United States, 85715
3
Microbia Investigational Site
Sherwood, Arkansas, United States, 72120
4
Microbia Investigational Site
Anaheim, California, United States