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
Verified date | September 2023 |
Source | Ardelyx |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Ardelyx |
United States,
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 |
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