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.
A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
At a glance
Conditions
Where it's being run
109 sites across 33 statesStudy leadership
- Brian Quach · STUDY_DIRECTOR · Ardelyx Inc
Who to contact
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What this trial measures
- 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