Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ironwood Pharmaceuticals, Inc.
With
Forest Laboratories
The trial also included a 145 ug linaclotide treatment arm (an FDA-approved dose for CIC) as an established positive control to validate the study design.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient has completed a colonoscopy if one is needed according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings
Patient has no clinically significant findings on a physical examination and clinical laboratory tests
Patient meets protocol criteria for CIC: reports \< 3 bowel movements (BMs) per week and reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard stools, sensation of incomplete evacuation during the 3 months before the diagnosis with the onset at least 6 months before the diagnosis
Patient is compliant with daily interactive voice response system (IVRS) calls
Patient reports an average of \< 3 complete spontaneous BMs (CSBMs) and ≤ 6 SBMs per week by the IVRS over the 14 calendar days before the Randomization Visit and the calendar day of Randomization.
You may not be if
Patient has 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 could confound the study assessments
Patient has Bristol Stool Form Scale score of 7 during Pretreatment period.
Clareo Health | Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
