CompletedPhase 3

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

United States312 participantsStarted 2016-03

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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methods of barrier contraception or have documented surgical sterilization Exclusion Criteria: * Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302 * The subject reports using any prohibited medication and is not willing to abide by the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

What they're measuring

Adverse Events in >2% Patients

Timeframe: 52-55 weeks

Trial details

NCT IDNCT02727751

SponsorArdelyx

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-10

Results submitted2020-04-10

View on ClinicalTrials.gov More Constipation Predominant Irritable Bowel Syndrome trials