Tenapanor for Chronic Idiopathic Constipation

This study is looking at how safe and effective a medication called tenapanor is for adults with Chronic Idiopathic Constipation (CIC). CIC is a type of long-lasting constipation without a known cause. You would receive tenapanor at one of three different doses (5 mg, 25 mg, or 50 mg, twice a day) or a placebo (a pill with no medicine). The main goal is to see if tenapanor helps you have regular, complete bowel movements. Adults aged 18 to 80 who meet specific criteria for functional constipation can join. The study status is currently unclear.

Study design
This is a 26-week, multi-center study where participants are randomly assigned to receive tenapanor or a placebo. It is double-blind, meaning neither you nor your doctors will know which treatment you are receiving. About 692 people are planned to join.
What's involved
You would have a 2-week screening period, followed by 26 weeks of treatment. During this time, you'll record your constipation symptoms daily in an electronic diary and attend clinic visits every 2 to 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
After the 26-week treatment, there is a 4-week period where you will not take the study medication, but your safety will still be monitored.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07382167

A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults

Recruiting
PHASE3Ages 18–80InterventionalTreatment
Ardelyx
~692 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Tenapanor 5 mg BIDTenapanor 25 mg BIDTenapanor 50 mg BIDPlacebo

At a glance

Recruiting sites
109 of 109 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Durable complete spontaneous bowel movements (CSBM) response
Measured over 12 Weeks
Chronic Idiopathic Constipation (CIC)
109 sites across 33 states
Florida10
North Carolina10
California9
Texas8
Louisiana6
Tennessee6
Ohio5
Arizona4
  • Brian Quach · STUDY_DIRECTOR · Ardelyx Inc

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  • Durable complete spontaneous bowel movements (CSBM) response12 Weeks

    Durable complete spontaneous bowel movements (CSBM) response is defined as achieving the weekly CSBM response for ≥9 out of the first 12 weeks of the randomized treatment period and and for ≥3 of the last 4 weeks of the first 12 weeks of randomized treatment period