Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ironwood Pharmaceuticals, Inc.
• Treatments: Linaclotide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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