NCT05643534Phase 3Completed

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

Study sponsor: Ardelyx

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-08-20Actual

Enrollment · participants180Actual

Source updated2026-09-22Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-09-22 · 3 fields changed

Completion date type

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Estimated

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Actual

Primary completion date

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2026-09-01

+ Updated value

2026-08-20

Recruitment status

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Active not recruiting

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Completed

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Posted 2026-06-04 · 3 fields changed

Participant count type

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Estimated

+ Updated value

Actual

Primary completion date

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− Previous value

2026-06-01

+ Updated value

2026-09-01

Recruitment status

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Recruiting

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Active not recruiting

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Posted 2026-01-12 · 1 field changed

Primary completion date

Recorded edit

− Previous value

2025-12-31

+ Updated value

2026-06-01

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Study details

Conditions studied

Irritable Bowel Syndrome With Constipation (IBS-C)

Treatments or interventions studied

Tenapanor 50 MGDrug
Tenapanor 25 mg bidDrug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: 6/12-week APS (abdominal pain and SBM) +2 response; description: 6/12-week APS (abdominal pain and SBM (spontaneous bowel movement)) +2 response, defined as achieving the weekly APS +2 response criteria (i.e., achieving both weekly SBM +2 response and weekly abdominal pain response during the same week) for ≥6 out of the 12 weeks of the RTP. * The weekly SBM +2 response is defined as having an increase of ≥2 from baseline in the average weekly SBM frequency for a given week * The weekly abdominal pain response is defined as having ≥30% reduction from baseline in the average weekly abdominal pain score for a given week; timeFrame: 12 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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