Tenapanor for Irritable Bowel Syndrome with Constipation
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old.
Will I have to stop taking my current medications?
Participants will need to stop taking any laxatives and medications that affect stool consistency, like fiber supplements, anti-diarrheals, and certain others, unless specified as rescue medication by the study doctor.
Is Tenapanor safe for humans?
Tenapanor has been evaluated in clinical trials for irritable bowel syndrome with constipation, and these studies have assessed its safety. It is minimally absorbed in the body, which may reduce the risk of side effects, and it has been approved by the FDA for this condition, indicating it has met safety standards.12345
How is the drug Tenapanor unique for treating IBS-C?
Tenapanor is unique because it is a first-in-class drug that works by inhibiting a specific protein in the gut, called the sodium/hydrogen exchanger 3 (NHE3), which helps reduce the absorption of sodium and water, thereby easing constipation. Unlike traditional treatments that mainly address symptoms, Tenapanor targets a novel mechanism in the gut, offering a new approach for managing IBS-C.23456
What data supports the effectiveness of the drug Tenapanor for treating irritable bowel syndrome with constipation?
Who Is on the Research Team?
David Rosenbaum, PhD
Principal Investigator
Ardelyx
Are You a Good Fit for This Trial?
This trial is for children aged 6 to less than 12 years who have Irritable Bowel Syndrome with Constipation (IBS-C). The key eligibility details are not provided, so it's important to check the specific requirements before joining.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomized Treatment Period
Participants receive tenapanor or placebo and record daily assessments in the eDiary
Follow-up
Participants undergo a treatment-free period with safety assessments
What Are the Treatments Tested in This Trial?
Interventions
- Tenapanor
Tenapanor is already approved in United States for the following indications:
- Irritable Bowel Syndrome with Constipation (IBS-C)
- Chronic Kidney Disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ardelyx
Lead Sponsor