Clinical trial NCT05905926: Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C
Official title: An Open-Label Long-Term Safety Study of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 6 to Less Than 18 Years Old
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)
Lead sponsor: Ardelyx
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.

Detailed description: Open-label long-term safety study of tenapanor in pediatric patients with IBS-C. Eligible patients who complete the parent study will have an option to enroll in this study.

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.

Eligibility criteria: Inclusion Criteria:

1. ≥6 and \<18 years old at enrollment of either parent study
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:

1. Patient discontinued prematurely from the parent study.
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

Primary outcomes:
measure: Safety Measure Assessment (Adverse Event)
timeFrame: 40 weeks
measure: Safety Measure Assessment (ECG)
timeFrame: 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Foley
country: United States
facility: G & L Research, LLC
state: Alabama
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Doral
country: United States
facility: Prohealth Research Center
state: Florida
city: Kissimmee
country: United States
facility: I.H.S. Health, LLC
state: Florida
city: Miami
country: United States
facility: Valencia Medical and Research Center
state: Florida
city: South Miami
country: United States
facility: Florida Pharmaceutical Research and Associates, Inc.
state: Florida
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Boys Town
country: United States
facility: Boys Town National Research Hospital
state: Nebraska
city: Bronx
country: United States
facility: Advantage Clinical Trials
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Scottdale
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health Children's Hospital
state: South Carolina
city: El Paso
country: United States
facility: Maspons Pediatric Gastro
state: Texas
city: Harlingen
country: United States
facility: Texas Digestive Specialists
state: Texas
city: Plano
country: United States
facility: AIM Trials, LLC
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Sugar Land
country: United States
facility: Pioneer Research Solutions Inc
state: Texas
city: Kingwood
country: United States
facility: Frontier Clinical Research
state: West Virginia
Study officials:
affiliation: Ardelyx
name: David Rosenbaum
role: STUDY_CHAIR
References: