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

NCT02727751 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2020-09-09

Study results available
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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.

Conditions

  • Constipation Predominant Irritable Bowel Syndrome

Interventions

DRUG

Tenapanor

Sponsors & Collaborators

  • Ardelyx

    lead INDUSTRY

Principal Investigators

  • David P Rosenbaum, Ph.D. · Ardelyx, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02727751 on ClinicalTrials.gov