Actively Recruiting
Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years
Led by Ardelyx · Updated on 2026-01-12
180
Participants Needed
41
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of tenapanor (25 mg and 50 mg) in pediatric patients (≥12 and \<18 years old) with IBS-C when administered twice daily (BID) for 12 consecutive weeks.
CONDITIONS
Official Title
Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 12 to less than 18 years
- Weigh at least 18 kg at the time of written assent
- Females who can have children must test negative for pregnancy and agree to use birth control or abstain
- Meet Rome IV child/adolescent criteria for IBS-C diagnosis
- Willing to stop any laxatives except protocol-approved rescue medicine after 72 hours without bowel movement
- Meet eligibility based on assessments during the 2-week screening
- Ability of patient and parent/guardian to communicate with study staff and follow study requirements including eDiary use
- Patient must provide written assent and parent/guardian must provide informed consent before study procedures
You will not qualify if you...
- Have functional diarrhea or IBS types other than IBS-C (IBS-D, IBS-M, or unsubtyped IBS) by Rome IV child/adolescent criteria
- History of non-retentive fecal incontinence
- Required manual disimpaction before randomization
- Have unexplained or significant alarm symptoms (such as GI bleeding, anemia, weight loss) with systemic infection signs or colitis or cancer
- Have celiac disease, cystic fibrosis, untreated or treated hypothyroidism, Down's syndrome or other chromosomal disorders
- Have active anal fissure, anatomical malformations, intestinal nerve or muscle disorders, neuropathic conditions, lead toxicity, or hypercalcemia
- Have neurodevelopmental disabilities that prevent understanding or completing the eDiary
- Have inflammatory bowel disease or childhood functional abdominal pain syndromes
- Have poorly treated psychiatric disorders affecting participation
- Have lactose intolerance causing abdominal pain or discomfort
- History of cancer except treated basal cell carcinoma with remission for at least 5 years
- History of diabetic neuropathy
- Use medications affecting stool consistency during screening unless as rescue medication
- Have had certain surgeries including bariatric, GI segment removal, recent abdominal/pelvic surgery, or recent appendectomy or cholecystectomy
- History of alcohol or substance abuse
- Participated in other clinical trials within 1 month before screening
- Involved in the conduct or administration of this trial or related to staff members
- Unable or unwilling to follow protocol or with conditions affecting study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 41 locations
1
G & L Research, LLC
Foley, Alabama, United States, 36535
Completed
2
Eclipse Clinical Research
Tucson, Arizona, United States, 85745
Actively Recruiting
3
Advanced Research Center, Inc.
Anaheim, California, United States, 92805
Actively Recruiting
4
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
5
Prohealth Research Center
Doral, Florida, United States, 33166
Actively Recruiting
6
I.H.S. Health, LLC
Kissimmee, Florida, United States, 34741
Terminated
7
Waterway Research & Associates Corp
Miami, Florida, United States, 33155
Actively Recruiting
8
Valencia Medical and Research Center
Miami, Florida, United States, 33165
Actively Recruiting
9
Orlando Health, Inc.- APH Center for Digestive Health and Nutrition
Orlando, Florida, United States, 32806
Actively Recruiting
10
Florida Pharmaceutical Research and Associates, Inc.
South Miami, Florida, United States, 33143
Actively Recruiting
11
Clinical Research Institute
Stockbridge, Georgia, United States, 30281
Completed
12
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Actively Recruiting
13
Riley Children's Health IUH
Indianapolis, Indiana, United States, 46202
Actively Recruiting
14
Maine Health
Portland, Maine, United States, 04102
Actively Recruiting
15
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
16
Mankato Clinic/ Javara Research Ltd
Mankato, Minnesota, United States, 56001
Actively Recruiting
17
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Withdrawn
18
Boys Town National Research Hospital
Boys Town, Nebraska, United States, 68010
Actively Recruiting
19
Med Clinical Research Partners, LLC
Irvington, New Jersey, United States, 07111
Actively Recruiting
20
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131
Completed
21
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Actively Recruiting
22
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
23
Advantage Clinical Trials
The Bronx, New York, United States, 10467
Completed
24
Atrium Health
Charlotte, North Carolina, United States, 28203
Actively Recruiting
25
Duke University School of Medicine
Durham, North Carolina, United States, 27705
Actively Recruiting
26
M3 Wake Research, Inc
Raleigh, North Carolina, United States, 27612
Withdrawn
27
Wilmington Health
Wilmington, North Carolina, United States, 28401
Actively Recruiting
28
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States, 15683
Actively Recruiting
29
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States, 15478
Actively Recruiting
30
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States, 02818
Withdrawn
31
Prisma Health Children's Hospital
Greenville, South Carolina, United States, 29615
Actively Recruiting
32
Advance Clinical Trial PLLC
Abilene, Texas, United States, 79606
Actively Recruiting
33
Maspons Pediatric Gastro
El Paso, Texas, United States, 79902
Actively Recruiting
34
Proactive El Paso, LLC
El Paso, Texas, United States, 79902
Actively Recruiting
35
Texas Digestive Specialists
Harlingen, Texas, United States, 78550
Actively Recruiting
36
AIM Trials, LLC
Plano, Texas, United States, 75093
Completed
37
Sun Research Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
38
Pioneer Research Solutions Inc
Sugar Land, Texas, United States, 77479
Actively Recruiting
39
ClinPoint Trials
Waxahachie, Texas, United States, 75165
Actively Recruiting
40
University Physicians and Surgeons, Inc.
Huntington, West Virginia, United States, 25701
Actively Recruiting
41
Frontier Clinical Research
Kingwood, West Virginia, United States, 26537
Actively Recruiting
Research Team
J
Jocelyn Tabora
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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