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Phosphate Absorption Inhibitor

Tenapanor for Pediatric IBS with Constipation

Q: Am I eligible to contribute my data to this clinical research?

This clinical trial is seeking 150 participants with irritable bowel syndrome between the ages of 6 and 18.

Q: Has Tenapanor achieved regulatory clearance by the FDA?

Drawing from the available evidence, our team at Power assigned Tenapanor a score of 3 on the safety scale due to its Phase 3 status--which implies that efficacy has been established and validated by multiple rounds of data.

Q: Is the research open to octogenarians?

This medical trial seeks pediatric participants aged 6 to 18 years.

Q: Does this experiment currently have open slots for participants?

This particular trial is not presently recruiting any participants. It was initially posted on February 17th, 2023 and the information has since been updated as recently as June 13th, 2023. Fortunately for patients searching for trials, there are 1,534 other studies actively seeking enrolment at this time.

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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 40 weeks

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

Covid-19

Pneumonia

Peritonitis

Chest Pain

Hypoglycemia

Hyperkalemia

Fluid Overload

Cerebrovascular Accident

Arteriovenous Fistula Site Infection

Catheter Site Infection

Influenza

Ulna Fracture

Nausea

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

ArdelyxLead Sponsor

27 Previous Clinical Trials

5,863 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

Frequently Asked Questions

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

Am I eligible to contribute my data to this clinical research?

"This clinical trial is seeking 150 participants with irritable bowel syndrome between the ages of 6 and 18."

Answered by AI

Has Tenapanor achieved regulatory clearance by the FDA?

"Drawing from the available evidence, our team at Power assigned Tenapanor a score of 3 on the safety scale due to its Phase 3 status--which implies that efficacy has been established and validated by multiple rounds of data."

Answered by AI

Is the research open to octogenarians?

"This medical trial seeks pediatric participants aged 6 to 18 years."

Answered by AI

Does this experiment currently have open slots for participants?

"This particular trial is not presently recruiting any participants. It was initially posted on February 17th, 2023 and the information has since been updated as recently as June 13th, 2023. Fortunately for patients searching for trials, there are 1,534 other studies actively seeking enrolment at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

2023. "Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05905926.

All > Irritable Bowel Syndrome > Ibs