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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05905926
Other study ID # TEN-01-306
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT03471728 - Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
Recruiting NCT05643534 - Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years Phase 3
Recruiting NCT05240521 - Efficacy and Safety, Tolerability of GA-AT0119 in IBS-C N/A
Completed NCT02495623 - A Study of the Effect of SYN-010 on Subjects With IBS-C Phase 2
Completed NCT01880424 - A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C) Phase 3
Completed NCT02078323 - Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients N/A