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Therapeutic Areas: Gastroenterology
Disease Category: Constipation

Trial Information

Seeking volunteers at least 18 years old who are experiencing symptoms of chronic constipation to take part in this clinical study.

Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administrered Orally for 12 Weeks in Patients With Chronic Constipation.

Inclusion Criteria:
Qualified paticipants will:

• Have completed a colonoscopy with no clinical significant findings
• Have successfully completed protocol procedures (with no clinically significant findings): study related physical exam, 12-lead ECG, or clinical laboratory tests
• Meet protocol criteria for Chronic constipation: reports less than 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during more than 25% of BMs
Demonstrate continued chronic constipation through pre study treatment period
• Compliance with automated diary and have access to a touch-tone phone for completion of daily diary calls.

Exclusion Criteria:
Participants must not have:

• History of loose or watery stools
• Symptoms of or have been diagnosed with Irritable Bowel Syndrome (IBS)
• A structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility

Emerald Coast Research Associates
Located in:
Panama City, FL 32405

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