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Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

Join a study on Tenapanor for kids with IBS-C, ages 12-17.

Recruiting
12-17 years
All
Phase 3

This study is for kids aged 12 to 17 with IBS-C, a tummy problem where you get constipated often. The study checks how safe and effective tenapanor, a medicine, is for treating IBS-C. Participants will be divided into groups to receive either tenapanor or a placebo (a pill with no medicine) for 12 weeks. They must use an eDiary, a special device to record their symptoms every day. The study starts with a 2-week screening to see if kids are eligible. During the 12 weeks, they will visit the study center every two to four weeks for safety checks.

  • The study lasts for about 3 months, with several visits to the clinic.
  • Participants will use an electronic diary to track their symptoms daily.
  • Eligible participants must be willing to stop using other laxatives during the study.

If you have certain health conditions, like celiac disease or recent surgeries, you might not be able to join. It's important to talk with your parents and doctor to see if this study is right for you. Participants will not be given compensation for participating in this study.

Study details
    Irritable Bowel Syndrome With Constipation (IBS-C)

NCT05643534

Ardelyx

30 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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