Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

Irritable Bowel Syndrome With Constipation (IBS-C) Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05905926
• Other study ID #: TEN-01-306
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: February 17, 2023
• Est. completion date: October 2031

Study information

• Verified date: September 2023
• Source: Ardelyx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: October 2031
• Est. primary completion date: July 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Constipation (IBS-C)
• Syndrome

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Advanced Research Center, Inc.	Anaheim	California
United States	Prohealth Research Center	Doral	Florida
United States	G & L Research, LLC	Foley	Alabama
United States	Texas Digestive Specialists	Harlingen	Texas
United States	Frontier Clinical Research, LLC	Kingwood	West Virginia
United States	I.H.S. Health, LLC	Kissimmee	Florida
United States	Valencia Medical and Research Center	Miami	Florida
United States	AIM Trials, LLC	Plano	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	Frontier Clinical Research, LLC	Scottdale	Pennsylvania
United States	Frontier Clinical Research, LLC	Smithfield	Pennsylvania
United States	Florida Pharmaceutical Research and Associates, Inc.	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ardelyx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by MedDRA v26.0	To evaluate the difference in % adverse events between Placebo and Tenapanor to assess the long term safety	40 weeks
Secondary	Change in alanine aminotransferase (ALT) serum chemistry value (IU/L)	To evaluate change from baseline values in tenapanor group versus placebo to assess long term safety	Change from baseline to week 40
Secondary	Change in aspartate aminotransferase (AST) serum chemistry value (IU/L)	To evaluate change from baseline values in tenapanor group versus placebo to assess long term safety	Change from baseline to week 40
Secondary	Change in serum creatinine value (mg/dL)	To evaluate change from baseline values in tenapanor group versus placebo to assess long term safety	Change from baseline to week 40