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Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) - NCT00938717-06011(Clinical Trial 301684)



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City:  Bristol
State:  
CT
Zip Code: 06011
Conditions: Irritable Bowel Syndrome With Constipation
Purpose: The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).
Study summary:
Criteria: Inclusion Criteria: - Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings - Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests - Patient meets protocol criteria for diagnosis of IBS-C - Patient demonstrates continued IBS-C through Pretreatment Period - Patient is compliant with IVRS Exclusion Criteria: - Patient has history of loose or watery stools - Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain - 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
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2010
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