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Phosphate Absorption Inhibitor

Tenapanor for Pediatric IBS with Constipation

Phase 3
Waitlist Available
Research Sponsored by Ardelyx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥6 and <18 years old at enrollment of either parent study
Subject is ambulatory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 weeks
Awards & highlights

Summary

This trial studies how safe a drug called tenapanor is for kids with a digestive condition called IBS-C.

Who is the study for?
This trial is for children and teenagers aged between 6 and under 18 who have Irritable Bowel Syndrome with Constipation (IBS-C). They must have completed a previous study on this condition, followed the procedures well, and be able to walk. Girls who can have babies need a negative pregnancy test and must use birth control.Check my eligibility
What is being tested?
The trial is testing Tenapanor, which is being considered as a long-term treatment option for young patients with IBS-C. It's an open-label study, meaning everyone knows they're getting Tenapanor without any placebo or comparison drug involved.See study design
What are the potential side effects?
While not specified here, common side effects of medications like Tenapanor could include digestive issues such as diarrhea or nausea, abdominal pain, headache, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 6 and 17 years old.
Select...
I can walk on my own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 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
Number of participants with treatment-related adverse events as assessed by MedDRA v26.0
Secondary outcome measures
Change in alanine aminotransferase (ALT) serum chemistry value (IU/L)
Change in aspartate aminotransferase (AST) serum chemistry value (IU/L)
Change in serum creatinine value (mg/dL)

Side effects data

From 2021 Phase 4 trial • 333 Patients • NCT04549597
42%
Diarrhea
3%
Covid-19
3%
Pneumonia
2%
Peritonitis
1%
Chest Pain
1%
Hypoglycemia
1%
Hyperkalemia
1%
Fluid Overload
1%
Cerebrovascular Accident
1%
Arteriovenous Fistula Site Infection
1%
Catheter Site Infection
1%
Influenza
1%
Ulna Fracture
1%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2
Cohort 3: Phosphate Binder Naïve
Cohort 1

Trial Design

1Treatment groups
Experimental Treatment
Group I: TenapanorExperimental Treatment1 Intervention
Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg BID or 25 mg BID per Investigator guidance after a patient's first week on the assigned dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenapanor
2016
Completed Phase 4
~4030

Find a Location

Who is running the clinical trial?

ArdelyxLead Sponsor
28 Previous Clinical Trials
5,893 Total Patients Enrolled
7 Trials studying Irritable Bowel Syndrome
2,263 Patients Enrolled for Irritable Bowel Syndrome
David RosenbaumStudy ChairArdelyx

Media Library

Tenapanor (Phosphate Absorption Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05905926 — Phase 3
Irritable Bowel Syndrome Research Study Groups: Tenapanor
Irritable Bowel Syndrome Clinical Trial 2023: Tenapanor Highlights & Side Effects. Trial Name: NCT05905926 — Phase 3
Tenapanor (Phosphate Absorption Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05905926 — Phase 3
~100 spots leftby Jul 2031
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