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Phosphate Absorption Inhibitor

Tenapanor for Irritable Bowel Syndrome with Constipation

Phase 3
Recruiting
Research Sponsored by Ardelyx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial tests a drug in 12- to 18-year-olds with IBS-C to see if it's safe, effective and tolerable.

Who is the study for?
This trial is for kids and teens aged 12 to under 18 with IBS-C (constipation type). They must weigh at least 18 kg, not be pregnant, agree to use birth control if applicable, and can't have had certain surgeries or conditions that affect the gut. Participants need to stop other laxatives and follow study rules including using an eDiary.Check my eligibility
What is being tested?
The trial tests two doses of Tenapanor (25 mg and 50 mg) against a placebo in young patients with IBS-C. It's randomized and double-blind, meaning neither the participants nor the researchers know who gets which treatment. The medication is taken twice daily for three months.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include digestive issues like abdominal pain or discomfort due to Tenapanor's action on bowel movements. Side effects will be monitored closely throughout the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
6/12-week APS (abdominal pain and SBM) +2 response
Secondary outcome measures
6/12-week SBM +2 response
6/12-week abdominal pain response
Change from baseline in average weekly SBM frequency
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Tenpanor 50 mg BIDExperimental Treatment1 Intervention
Patients will be randomized to receive 50 mg tenapanor twice daily
Group II: Tenpanor 25 mg BIDExperimental Treatment1 Intervention
Patients will be randomized to receive 25 mg tenapanor twice daily
Group III: Placebo ComparatorPlacebo Group1 Intervention
Patients will be randomized to receive matching placebo twice daily

Find a Location

Who is running the clinical trial?

ArdelyxLead Sponsor
27 Previous Clinical Trials
5,833 Total Patients Enrolled
7 Trials studying Irritable Bowel Syndrome
2,233 Patients Enrolled for Irritable Bowel Syndrome
David Rosenbaum, PhDStudy ChairArdelyx

Media Library

Tenapanor (Phosphate Absorption Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05643534 — Phase 3
Irritable Bowel Syndrome Research Study Groups: Placebo Comparator, Tenpanor 50 mg BID, Tenpanor 25 mg BID
Irritable Bowel Syndrome Clinical Trial 2023: Tenapanor Highlights & Side Effects. Trial Name: NCT05643534 — Phase 3
Tenapanor (Phosphate Absorption Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05643534 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age of 45 a threshold for recruitment into this investigation?

"This clinical trial requires that participants are aged between 12 and 17. There are 399 trials for minors, and 1075 for seniors."

Answered by AI

Are there any available slots for this research project at the current time?

"According to the clinicaltrials.gov listing, this medical trial is actively enrolling patients as of November 30th 2022, having been posted on 15/11/2022."

Answered by AI

To what extent can Tenpanor 50 mg BID be considered a secure treatment option?

"Tenpanor 50 mg BID has been assessed to be of a safety grade 3, as the Phase 3 trial demonstrated efficacy and multiple rounds that provided solid evidence for its security."

Answered by AI

What is the maximum number of participants for this clinical trial?

"That is correct. According to the clinicaltrials.gov listing, this medical trial that first opened its doors on November 15th 2022 is presently enrolling participants and has recently been updated (November 30th). Currently 180 patients need to be enrolled from a single location."

Answered by AI

Am I qualified to participate in this research?

"To be considered for this trial, adolescent patients with constipation-predominant irritable bowel syndrome (ibs-c) aged 12 to 17 can submit an application. The study seeks 180 participants in total."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Sun Research Institute
Boys Town National Research Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years
2022. "Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05643534.
All > Irritable Bowel Syndrome > Ibs
~97 spots leftby Dec 2025
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