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

Conditions

• Constipation Predominant Irritable Bowel Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Tenapanor — DRUG
• Placebo — DRUG

Study Details

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.

Key Dates

Start date

Dec 31, 2015

Status verified

Apr 2020

Primary completion

Aug 31, 2017

Completion

Oct 31, 2017

Study Design

Enrollment

593 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 50mg BID
  Tenapanor, 50mg BID (100mg total)
• Placebo Comparator: Placebo
  Placebo

Primary Outcome Measure

Percentage of Subjects With Overall Response for 6 Out of 12 Weeks [ Time Frame: First 12 weeks ]

Locations (117)

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