RecruitingPhase 2

4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs

United States72 participantsStarted 2024-07-24

Plain-language summary

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.

Who can participate

Age range6 Years – 11 Years

SexALL

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Inclusion criteria

✓. ≥6 and \<12 years old at the Screening visit (Visit 1)
✓. Confirmation of negative pregnancy test and use of appropriate contraceptive (including abstinence) in female subjects that have experienced menarche and are of child-bearing potential.
✓. Meet the Modified Diagnostic Rome IV criteria for child/adolescent diagnosis of IBS-C
✓. Patient is willing to discontinue any laxatives used in favor of the protocol-permitted rescue medicine (which will only be allowed after 72 hours with no bowel movement)
✓. Meet the entry criteria assessed during the 2-week Screening period
✓. Ability of both the patient and parent/guardian/LAR to communicate with the Investigator and to comply with the requirements of the entire study, including an understanding of the assessments in the eDiary and how to use the eDiary device
✓. Patient must provide verbal assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures

Exclusion criteria

✕. Functional diarrhea as defined by Modified Rome IV child/adolescent criteria
✕. IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Modified Rome IV child/adolescent criteria
✕. History of non-retentive fecal incontinence;
✕. Required manual disimpaction any time prior to randomization (after consent)
✕. Currently has both unexplained and clinically significant alarm symptoms (lower gastrointestinal \[GI\] bleeding \[rectal bleeding or heme-positive stool\], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process.
✕. Patient has any of the following conditions:
✕. Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy;
✕. Cystic fibrosis;

What they're measuring

Average weekly SBM (week 4)

Timeframe: 4 weeks

Trial details

NCT IDNCT06553547

SponsorArdelyx

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Jocelyn Tabora

510-745-1724 jtabora@ardelyx.com

View on ClinicalTrials.gov More Irritable Bowel Syndrome With Constipation (IBS-C) trials