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

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ardelyx

Criteria

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• Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302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