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Tenapanor for the Treatment of Pediatric Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Primary Purpose

Irritable Bowel Syndrome With Constipation (IBS-C)

Status
Enrolling by invitation
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tenapanor
Sponsored by
Ardelyx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Irritable Bowel Syndrome With Constipation (IBS-C)

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥6 and <18 years old at enrollment of either parent study Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator 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). Subject is ambulatory 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: Patient discontinued prematurely from the parent study. Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy Pregnant or lactating women If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol

Sites / Locations

  • G & L Research, LLC
  • Advanced Research Center, Inc.
  • Prohealth Research Center
  • Valencia Medical and Research Center
  • Florida Pharmaceutical Research and Associates, Inc.
  • Frontier Clinical Research, LLC
  • Frontier Clinical Research, LLC
  • AIM Trials, LLC
  • Sun Research Institute
  • Frontier Clinical Research, LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tenapanor

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 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 in serum creatinine value (mg/dL)
To evaluate change from baseline values in tenapanor group versus placebo to assess long term safety

Full Information

First Posted
March 7, 2023
Last Updated
September 6, 2023
Sponsor
Ardelyx
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1. Study Identification

Unique Protocol Identification Number
NCT05905926
Brief Title
Tenapanor for the Treatment of Pediatric Patients With Irritable Bowel Syndrome With Constipation (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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 17, 2023 (Actual)
Primary Completion Date
July 2031 (Anticipated)
Study Completion Date
October 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ardelyx

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Constipation (IBS-C)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Open label study
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥6 and <18 years old at enrollment of either parent study Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator 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). Subject is ambulatory 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: Patient discontinued prematurely from the parent study. Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy Pregnant or lactating women If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Rosenbaum
Organizational Affiliation
Ardelyx
Official's Role
Study Chair
Facility Information:
Facility Name
G & L Research, LLC
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
Facility Name
Advanced Research Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Prohealth Research Center
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Valencia Medical and Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Florida Pharmaceutical Research and Associates, Inc.
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Frontier Clinical Research, LLC
City
Scottdale
State/Province
Pennsylvania
ZIP/Postal Code
15683
Country
United States
Facility Name
Frontier Clinical Research, LLC
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
AIM Trials, LLC
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Frontier Clinical Research, LLC
City
Kingwood
State/Province
West Virginia
ZIP/Postal Code
26537
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Tenapanor for the Treatment of Pediatric Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

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