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

Completed · Phase 3

Conditions studied: Constipation Predominant Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT02727751

Run by

Ardelyx

People needed

312

Starts

2016-03-01

Expected to finish

2017-10-01

Last updated by the study team

2020-09-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302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

Where it is running

• Ardelyx Clinical Site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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