A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C (NCT02686138) | Clinical Trial Compass
CompletedPhase 3
A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C
United States593 participantsStarted 2015-12
Plain-language summary
This phase 3, 26-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of one dose of Tenapanor in subjects with constipation-predominant irritable bowel syndrome (IBS-C) as defined by the ROME III criteria and who have active disease as determined after a two-week screening period. Subjects who qualify and are randomized into the study will either receive 50mg BID of Tenapanor (1:1) for a 26 week treatment period.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Males or females aged 18 to 75 years, inclusive
* Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception
* Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization
* Subject meets definition of IBS-C using Rome III Criteria for the Diagnosis of IBS
* A colonoscopy based on AGA guidelines; every 10 years at ≥50 years old
Exclusion Criteria:
* Functional diarrhea as defined by Rome III criteria
* IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome III criteria
* Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract within 6 months prior to screening, or active disease within 6 months prior to screening; including but not limited to cancer, inflammatory bowel disease, diverticulitis, duodenal ulcer, erosive esophagitis, gastric ulcer, pancreatitis (within 12 months of screening), cholelithiasis, amyloidosis, ileus, non-controlled GERD, gastrointestinal obstruction or carcinoid syndrome.
* Potential CNS cause of constipation (e.g., Parkinson's disease, spinal cord injury, or multiple sclerosis)
* Subject has a history or current evidence of laxative abuse (in the clinical judgment of physician)
* Hepatic dysfunction (ALT \[SGPT\] or AST \[SGOT\] \>2.5 times the upper limit of normal) or renal imp…
What they're measuring
1
Percentage of Subjects With Overall Response for 6 Out of 12 Weeks