Could this pill ease tummy troubles for kids with IBS-C?
NCT ID NCT06553547
First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times
Summary
This study tests a medicine called tenapanor in children aged 6 to 12 who have irritable bowel syndrome with constipation (IBS-C). The goal is to see if it safely improves bowel movements and reduces belly discomfort. About 72 children will receive either the drug or a placebo for 4 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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72 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Jul 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 11 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Akron Children's Hospital
Akron, Ohio, 44308, United States
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Applied Research Center of Arkansas
Little Rock, Arkansas, 72205, United States
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Boys Town National Research Hospital
Boys Town, Nebraska, 68010, United States
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Clinical Research Partners, LLC
Richmond, Virginia, 23226, United States
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Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
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Florida Pharmaceutical Research and Associates, Inc.
South Miami, Florida, 33143, United States
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Mankato Clinic Children's Health Center
Mankato, Minnesota, 56001, United States
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Maspons Pediatric Gastro
El Paso, Texas, 79902, United States
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OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
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Orlando Health, Inc.- APH Center for Digestive Health and Nutrition
Orlando, Florida, 32806, United States
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Pioneer Research Solutions Inc
Sugar Land, Texas, 77479, United States
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Prisma Health Children's Hospital
Greenville, South Carolina, 29615, United States
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Proactive El Paso, LLC
El Paso, Texas, 79902, United States
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SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
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Sun Research Institute
San Antonio, Texas, 78215, United States
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Texas Digestive Specialists
Harlingen, Texas, 78550, United States
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University Physicians and Surgeons, Inc
Huntington, West Virginia, 25701, United States
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Valencia Medical and Research Center
Miami, Florida, 33165, United States
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Waterway Research & Associates Corp.
Miami, Florida, 33155, United States
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Wilmington Health
Wilmington, North Carolina, 28401, United States
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