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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Ardelyx
Study ID
NCT06553547
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Irritable Bowel Syndrome With Constipation (IBS-C)

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Tenapanor — DRUG
    Tenapanor 5 mg/mL solution
  • Placebo — DRUG
    Matching Placebo solution

Study Details

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 Dates

Start date
Jul 24, 2024
Status verified
Jun 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
72 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tenapanor Cohort 1
    Tenapanor 2 mg BID
  • Experimental: Tenapanor Cohort 2
    Tenapanor 5 mg BID
  • Experimental: Tenapanor Cohort 3
    Tenapanor 10 mg BID
  • Experimental: Tenapanor Cohort 4
    Tenapanor 15 mg BID
  • Experimental: Tenapanor Cohort 5
    Tenapanor 20 mg BID
  • Experimental: Tenapanor Cohort 6
    Tenapanor 25 mg BID
  • Placebo Comparator: Placebo
    Matching placebo

Primary Outcome Measure

Average weekly SBM (week 4) [ Time Frame: 4 weeks ]

Locations (20)

FacilityCityStateZIPSite coordinators
Applied Research Center of ArkansasLittle RockArkansas72205-
Connecticut Children's Medical CenterHartfordConnecticut06106-
Valencia Medical and Research CenterMiamiFlorida33165-
Waterway Research & Associates Corp.MiamiFlorida33155-
Orlando Health, Inc.- APH Center for Digestive Health and NutritionOrlandoFlorida32806-
Florida Pharmaceutical Research and Associates, Inc.South MiamiFlorida33143-
OSF Saint Francis Medical CenterPeoriaIllinois61637-
Mankato Clinic Children's Health CenterMankatoMinnesota56001-
Boys Town National Research HospitalBoys TownNebraska68010-
SUNY Downstate Medical CenterBrooklynNew York11203-
Wilmington HealthWilmingtonNorth Carolina28401-
Akron Children's HospitalAkronOhio44308-
Prisma Health Children's HospitalGreenvilleSouth Carolina29615-
Maspons Pediatric GastroEl PasoTexas79902-
Proactive El Paso, LLCEl PasoTexas79902-
Texas Digestive SpecialistsHarlingenTexas78550-
Sun Research InstituteSan AntonioTexas78215-
Pioneer Research Solutions IncSugar LandTexas77479-
Clinical Research Partners, LLCRichmondVirginia23226-
University Physicians and Surgeons, IncHuntingtonWest Virginia25701-

Find similar trials in Little Rock, AR

By research site
Applied Research Center of Arkansas· Little Rock, ARConnecticut Children's Medical Center· Hartford, CTValencia Medical and Research Center· Miami, FLWaterway Research & Associates Corp.· Miami, FLOrlando Health, Inc.- APH Center for Digestive Health and Nutrition· Orlando, FLFlorida Pharmaceutical Research and Associates, Inc.· South Miami, FL

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