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

NCT06553547 | Recruiting Phase 2 FDA Drug

• 1 other identifier: TEN-01-202
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Irritable Bowel Syndrome With Constipation (IBS-C)

Keywords

IBS-C

Outcome Measures

Primary Outcomes (1)

• Average weekly SBM (week 4)

  Change from baseline in average weekly SBM frequency in Week 4

  4 weeks

Secondary Outcomes (5)

• Average weekly SBM (weeks 1, 2 and 3)

  3 weeks

• SBM Response

  6 weeks

• Stool consistency

  6 weeks

• Abdominal Pain Score

  6 weeks

• Rescue medication

  6 weeks

Study Arms (7)

Tenapanor Cohort 1

EXPERIMENTAL

Tenapanor 2 mg BID

Drug: Tenapanor

Tenapanor Cohort 2

EXPERIMENTAL

Tenapanor 5 mg BID

Drug: Tenapanor

Tenapanor Cohort 3

EXPERIMENTAL

Tenapanor 10 mg BID

Drug: Tenapanor

Tenapanor Cohort 4

EXPERIMENTAL

Tenapanor 15 mg BID

Drug: Tenapanor

Tenapanor Cohort 5

EXPERIMENTAL

Tenapanor 20 mg BID

Drug: Tenapanor

Tenapanor Cohort 6

EXPERIMENTAL

Tenapanor 25 mg BID

Drug: Tenapanor

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Tenapanor DRUG

Tenapanor 5 mg/mL solution

Also known as: IBSRELA

Tenapanor Cohort 1; Tenapanor Cohort 2; Tenapanor Cohort 3; Tenapanor Cohort 4; Tenapanor Cohort 5; Tenapanor Cohort 6

Placebo DRUG

Matching Placebo solution

Placebo

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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;
• 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

Sponsors & Collaborators

• Ardelyx: lead

Study Sites (17)

Applied Research Center of Arkansas

Little Rock, Arkansas, 72205, United States

RECRUITING

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

RECRUITING

Waterway Research & Associates Corp.

Miami, Florida, 33155, United States

RECRUITING

Valencia Medical and Research Center

Miami, Florida, 33165, United States

RECRUITING

Orlando Health, Inc.- APH Center for Digestive Health and Nutrition

Orlando, Florida, 32806, United States

RECRUITING

Florida Pharmaceutical Research and Associates, Inc.

South Miami, Florida, 33143, United States

RECRUITING

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

RECRUITING

Mankato Clinic Children's Health Center

Mankato, Minnesota, 56001, United States

RECRUITING

Boys Town National Research Hospital

Boys Town, Nebraska, 68010, United States

RECRUITING

One Perkins Square

Akron, Ohio, 44308, United States

RECRUITING

Prisma Health Children's Hospital

Greenville, South Carolina, 29615, United States

RECRUITING

Maspons Pediatric Gastro

El Paso, Texas, 79902, United States

RECRUITING

Proactive El Paso, LLC

El Paso, Texas, 79902, United States

RECRUITING

Texas Digestive Specialists

Harlingen, Texas, 78550, United States

RECRUITING

Pioneer Research Solutions Inc

Sugar Land, Texas, 77479, United States

RECRUITING

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

RECRUITING

University Physicians and Surgeons, Inc

Huntington, West Virginia, 25701, United States

RECRUITING

MeSH Terms

Interventions

tenapanor

Study Officials

• Susan Edelstein, PhD

  Ardelyx

  STUDY DIRECTOR

Central Study Contacts

Jocelyn Tabora

CONTACT

510-745-1724; jtabora@ardelyx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 14, 2024
• Study Start: July 24, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)