A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C

Ardelyx312 enrolled

Overview

This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks) studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total based on previous protocol and this study.

During the treatment period of up to 39-weeks, subjects will return for study visits approximately every 13 weeks. Subjects will undergo safety assessments at these visits, which may include a physical exam, ECG, vital signs, and clinical labs. Adverse events and concomitant medications will be recorded. Medication compliance will be monitored and the subjects will be given additional study drug as appropriate.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

312

Conditions

Constipation Predominant Irritable Bowel Syndrome

Interventions

TenapanorDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects completed all 16 weeks of TEN-01-301 or all 26 weeks of TEN-01-302 * Subject demonstrated adequate compliance with the study procedures during either the TEN-01-301 or TEN-01-302 studies * Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception * Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization Exclusion Criteria: * Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302 * The subject reports using any prohibited medication and is not willing to abide by the restrictions for intake * Pregnant or lactating women

Locations (1)

Ardelyx Clinical Site

Miami, Florida, United States

Outcomes

Primary Outcomes

Adverse Events in >2% Patients

Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams

Time frame: 52-55 weeks

Data from ClinicalTrials.gov

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