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Completed

NCT Number: NCT02727751

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

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.

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Key information

Conditions

Constipation Predominant Irritable Bowel Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ardelyx Clinical Site

Miami, Florida, United States

About 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302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

Treatment and study plan

Tenapanor

Drug

Other names: RDX5791, AZD1722

Primary outcomes

  1. Adverse Events in >2% Patients

    Time frame: 52-55 weeks

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

Sponsors and collaborators

Lead sponsor

Ardelyx

Industry

Registry information

Official study title

An Open Label Long-Term Safety Study of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

Acronym: T3MPO-3

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 5, 2016
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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