NCT05643534
Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years
Active, Not Recruiting
PHASE3Ages 12–17InterventionalTreatmentArdelyx
~180 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Tenapanor 50 MGTenapanor 25 mg bidPlacebo
At a glance
Recruiting sites
0 of 39 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
6/12-week APS (abdominal pain and SBM) +2 response
Measured over 12 weeks
Conditions
Where it's being run
39 sites across 21 statesTexas8
Florida6
New York3
North Carolina3
Pennsylvania2
West Virginia2
Alabama1
Arizona1
Study leadership
- Jocelyn Tabora · STUDY_DIRECTOR · Ardelyx
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
≥12 and \<18 years old
Patient weighs ≥18 kg at the time the patient provides written assent
Females of child-bearing potential must have negative pregnancy test at Visit 1 (serum) and Visit 2 (urine) and confirm the use of appropriate contraception (including abstinence).
Patient meets the 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)
Patient meets 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 written assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures
Exclusion
Functional diarrhea as defined by Rome IV child/adolescent criteria
IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV child/adolescent criteria
History of non-retentive fecal incontinence.
Required manual disimpaction any time prior to randomization (after consent);
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
Cystic fibrosis
Hypothyroidism that is untreated or treated with thyroid hormone
Down's syndrome or any other chromosomal disorder
Active anal fissure
Anatomic malformations (eg, imperforate anus)
Intestinal nerve or muscle disorders (eg, Hirschprung disease)
Neuropathic conditions (eg, spinal cord abnormalities)
Lead toxicity, hypercalcemia
Neurodevelopmental disabilities producing a cognitive delay that precludes comprehension and completion of the daily eDiary (Electronic handheld device)
Inflammatory bowel disease
Childhood functional abdominal pain syndrome
Childhood functional abdominal pain;
Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study;
Lactose intolerance that is associated with abdominal pain or discomfort
History of cancer other than treated basal cell carcinoma of the skin; (Note: Patients with a history of cancer are allowed provided that the malignancy has been in a complete remission for at least 5 years before the Randomization Visit.)
History of diabetic neuropathy.
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.
Patient has had surgery that meets any of the following criteria:
Bariatric surgery for treatment of obesity, or surgery to remove a segment of the GI tract at any time before the Screening Visit;
Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit;
An appendectomy or cholecystectomy during the 60 days before the Screening Visit;
Other major surgery during the 30 days before the Screening Visit
History of alcohol or substance abuse
Participation in other clinical trials within 1 month prior to Screening
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
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
What this trial measures
- 6/12-week APS (abdominal pain and SBM) +2 response12 weeks
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