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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome With Constipation (IBS-C)

In brief

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.

Key facts

Study ID

NCT06553547

Run by

Ardelyx

People needed

72

Starts

2024-07-24

Expected to finish

2026-07-01

Last updated by the study team

2026-06-04

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• 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;
• 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;
• Down's syndrome or any other chromosomal disorder;
• Active anal fissure (Note: History of anal fissure is not an exclusion);
• Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus);
• Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies);
• Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma);
• Lead toxicity, hypercalcemia;
• Neurodevelopmental disabilities
• 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 and could confound the assessments in this study
• History of cancer other than treated basal cell carcinoma of the skin;
• 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:

Where it is running

• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Waterway Research & Associates Corp. — Miami, Florida, United States
• Valencia Medical and Research Center — Miami, Florida, United States
• Orlando Health, Inc.- APH Center for Digestive Health and Nutrition — Orlando, Florida, United States
• Florida Pharmaceutical Research and Associates, Inc. — South Miami, Florida, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• Mankato Clinic Children's Health Center — Mankato, Minnesota, United States
• Boys Town National Research Hospital — Boys Town, Nebraska, United States
• SUNY Downstate Medical Center — Brooklyn, New York, United States
• Wilmington Health — Wilmington, North Carolina, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Prisma Health Children's Hospital — Greenville, South Carolina, United States
• Maspons Pediatric Gastro — El Paso, Texas, United States
• Proactive El Paso, LLC — El Paso, Texas, United States
• Texas Digestive Specialists — Harlingen, Texas, United States
• Sun Research Institute — San Antonio, Texas, United States
• Pioneer Research Solutions Inc — Sugar Land, Texas, United States
• Clinical Research Partners, LLC — Richmond, Virginia, United States
• University Physicians and Surgeons, Inc — Huntington, West Virginia, United States

Full record on ClinicalTrials.gov

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