4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs
NCT ID: NCT06553547
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
72 participants
INTERVENTIONAL
2024-07-24
2026-06-30
Brief Summary
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Detailed Description
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During the 4 week RTP (Randomized treatment period), subjects will be randomized in in a ratio of 5:1 to receive tenapanor or matching placebo for 4 weeks. During the RTP, patients will continue recording daily assessments in the eDiary system as instructed and compliance with eDiary entries will be monitored. Patients will return for study visit every weeks (Visits 3-6) and will undergo safety assessments as per the protocol. At the end of this 4 week period, subjects will complete 2 week treatment free follow-up period and safety assessments per protocol will be conducted at the end of this 2 week period.
The study plans to enroll up to 6 cohorts of eligible patients sequentially, starting from Cohort 1 with 12 patients randomized in to receive tenapanor 2 mg BID or matching placebo for 4 weeks. Subsequent cohorts will assess increasing tenapanor doses, following a dose escalation order. The study will proceed to the next dosing cohort if the current cohort completes the 4-week RTP and does not meet any of the dose escalation stopping criteria pre-specified in the protocol.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tenapanor Cohort 1
Tenapanor 2 mg BID
Tenapanor
Tenapanor 5 mg/mL solution
Tenapanor Cohort 2
Tenapanor 5 mg BID
Tenapanor
Tenapanor 5 mg/mL solution
Tenapanor Cohort 3
Tenapanor 10 mg BID
Tenapanor
Tenapanor 5 mg/mL solution
Tenapanor Cohort 4
Tenapanor 15 mg BID
Tenapanor
Tenapanor 5 mg/mL solution
Tenapanor Cohort 5
Tenapanor 20 mg BID
Tenapanor
Tenapanor 5 mg/mL solution
Tenapanor Cohort 6
Tenapanor 25 mg BID
Tenapanor
Tenapanor 5 mg/mL solution
Placebo
Matching placebo
Placebo
Matching Placebo solution
Interventions
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Tenapanor
Tenapanor 5 mg/mL solution
Placebo
Matching Placebo solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
6 Years
11 Years
ALL
No
Sponsors
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Ardelyx
INDUSTRY
Responsible Party
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Principal Investigators
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Susan Edelstein, PhD
Role: STUDY_DIRECTOR
Ardelyx
Locations
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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
One Perkins Square
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
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TEN-01-202
Identifier Type: -
Identifier Source: org_study_id
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