A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C (T3MPO-3)

Ardelyx

Status and phase

Completed

Phase 3

Conditions

Constipation Predominant Irritable Bowel Syndrome

Treatments

Drug: Tenapanor

Study type

Interventional

Funder types

Industry

Identifiers

NCT02727751

TEN-01-303

Details and patient eligibility

About

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.

Full description

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.

Enrollment

312 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302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