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Testing tenapanor for treating constipation in children with IBS

4-Week, Multi-Center, Randomized, Db-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety & Efficacy of Tenapanor for the T/t of IBS-C in Pts. 6 to < 12 Yrs. Old

Phase 2 Interventional Ardelyx · NCT06553547

This study is testing if a new medication called tenapanor can help children aged 6 to under 12 with constipation caused by Irritable Bowel Syndrome feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment72 (estimated)
Ages6 Years to 11 Years
SexAll
SponsorArdelyx Industry-sponsored
Locations20 sites (Little Rock, Arkansas and 19 other locations)
Trial IDNCT06553547 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled dose-ranging study aimed at evaluating the safety and efficacy of tenapanor for treating Irritable Bowel Syndrome with Constipation (IBS-C) in pediatric patients aged 6 to less than 12 years. The study includes a 2-week screening period where participants will self-report their symptoms using an electronic diary. Following this, a 4-week randomized treatment period will involve administering either tenapanor or a matching placebo, with regular safety assessments and compliance monitoring. The study will sequentially enroll up to 6 cohorts, each receiving increasing doses of tenapanor based on pre-defined criteria.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to less than 12 years who meet the diagnostic criteria for IBS-C and are willing to comply with study requirements.

Not a fit: Patients who are not within the specified age range or who do not meet the diagnostic criteria for IBS-C may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective treatment option for children suffering from IBS-C, improving their quality of life.

How similar studies have performed: Other studies have shown promise in treating IBS-C with similar approaches, but this specific dose-ranging study is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. ≥6 and \<12 years old at the Screening visit (Visit 1)
2. 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.
3. Meet the Modified Diagnostic Rome IV criteria for child/adolescent diagnosis of IBS-C
4. 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)
5. Meet the entry criteria assessed during the 2-week Screening period
6. 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
7. 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:

1. Functional diarrhea as defined by Modified Rome IV child/adolescent criteria
2. IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Modified Rome IV child/adolescent criteria
3. History of non-retentive fecal incontinence;
4. Required manual disimpaction any time prior to randomization (after consent)
5. 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.
6. Patient has any of the following conditions:

   1. Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy;
   2. Cystic fibrosis;
   3. Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to the Screening Visit;
   4. Down's syndrome or any other chromosomal disorder;
   5. Active anal fissure (Note: History of anal fissure is not an exclusion);
   6. Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus);
   7. Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies);
   8. Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma);
   9. Lead toxicity, hypercalcemia;
   10. Neurodevelopmental disabilities
   11. Inflammatory bowel disease
   12. Childhood functional abdominal pain syndrome
   13. Childhood functional abdominal pain
   14. Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study;
   15. Lactose intolerance that is associated with abdominal pain or discomfort and could confound the assessments in this study
   16. History of cancer other than treated basal cell carcinoma of the skin;
   17. History of diabetic neuropathy.
7. Use of medications that are known to affect stool consistency (Prohibited Medications), including fiber supplements, anti-diarrheals, cathartics, antacids, opiates, prokinetic drugs, laxatives, enemas, antibiotics during the Screening period; unless specified as rescue medication, and used accordingly as directed by the Investigator.
8. Patient has had surgery that meets any of the following criteria:

   1. Surgery to remove a segment of the GI tract at any time before the Screening Visit;
   2. Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit;
   3. An appendectomy or cholecystectomy during the 60 days before the Screening Visit;
   4. Other major surgery during the 30 days before the Screening Visit
9. History of alcohol or substance abuse
10. Participation in other clinical trials within 1 month prior to Screening
11. Patient and/or parent/guardian/LAR is involved in the conduct and/or administration of this trial as an investigator, sub-investigator, trial coordinator, or other staff member, or the patient is a first-degree family member, significant other, or relative residing with one of the above persons involved in the trial
12. If, in the opinion of the Investigator, the patient is unable or unwilling to fulfill the requirements of the protocol or has a condition, which would render the results uninterpretable

Where this trial is running

Little Rock, Arkansas and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Irritable Bowel Syndrome With ConstipationIBS-C
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.