A 12-Week Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of 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, 12-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy 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 or placebo BID for 12 week treatment period and then undergo a 4 week placebo controlled randomized withdrawal.

Key Dates

Start date

Oct 31, 2015

Status verified

Apr 2020

Primary completion

Mar 31, 2017

Completion

Apr 30, 2017

Study Design

Enrollment

606 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 50mg BID
  Tenapanor
• Placebo Comparator: Placebo
  Placebo

Primary Outcome Measure

6 of 12 Week Overall Responder Rate [ Time Frame: 12 weeks ]

Locations (111)

Find similar trials in Birmingham, AL