Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C
NCT ID: NCT05905926
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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ENROLLING_BY_INVITATION
PHASE3
150 participants
INTERVENTIONAL
2023-02-17
2031-10-31
Brief Summary
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Detailed Description
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Patients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg BID or 25 mg BID per guidance in protocol after a patient's first week on the assigned dose. Patients will also return for study visits approximately every 6 weeks for safety assessments.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Tenapanor
Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg BID or 25 mg BID per Investigator guidance after a patient's first week on the assigned dose.
Tenapanor
Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study. Doses can be titrated to either 50 mg BID or 25 mg BID
Interventions
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Tenapanor
Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study. Doses can be titrated to either 50 mg BID or 25 mg BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator
3. Females of child-bearing potential must have negative pregnancy test at the last visit of the parent study and confirm the use of appropriate contraception (including abstinence).
4. Subject is ambulatory
5. Written informed consent by parent/guardian/ Legally Authorized Representative (LAR) and a willingness of both subject and parent/guardian/LAR to participate in the study as it is described
Exclusion Criteria
2. Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy
3. Pregnant or lactating women
4. If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol
6 Years
18 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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G & L Research, LLC
Foley, Alabama, United States
Advanced Research Center, Inc.
Anaheim, California, United States
Prohealth Research Center
Doral, Florida, United States
I.H.S. Health, LLC
Kissimmee, Florida, United States
Valencia Medical and Research Center
Miami, 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/ Javara Research Ltd
Mankato, Minnesota, United States
Boys Town National Research Hospital
Boys Town, Nebraska, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Advantage Clinical Trials
The Bronx, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Duke University School of Medicine
Durham, North Carolina, United States
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States
Prisma Health Children's Hospital
Greenville, South Carolina, United States
Maspons Pediatric Gastro
El Paso, Texas, United States
Texas Digestive Specialists
Harlingen, Texas, United States
AIM Trials, LLC
Plano, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Pioneer Research Solutions Inc
Sugar Land, Texas, United States
Frontier Clinical Research
Kingwood, West Virginia, United States
Countries
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Other Identifiers
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TEN-01-306
Identifier Type: -
Identifier Source: org_study_id
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