A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C



Status:Completed
Conditions:Constipation, Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/16/2019
Start Date:December 2015
End Date:October 2017

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A 26-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

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.

During the 26-week double-blind treatment period, subjects will record daily assessments
including: frequency and timing of bowel movements; sensation of complete bowel emptying;
consistency of bowel movements; degree of straining, worst abdominal pain, abdominal
discomfort, abdominal bloating, abdominal fullness and abdominal cramping; and use and timing
of rescue medication. Subjects will also record weekly assessments including: adequate relief
of IBS symptoms, degree of relief of IBS symptoms, IBS severity, and constipation severity.

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 impairment (serum creatinine >2 mg/dL)

- Any evidence of or treatment of malignancy (other than localized basal cell, squamous
cell skin cancer or cancer in situ that has been resected) within the previous year

- Any surgery on the stomach, small intestine or colon, excluding appendectomy and
cholecystectomy (unless within 60 days of screening visit)
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Anaheim, California 92801
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Albuquerque, New Mexico 87108
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