A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C
Part of paid clinical trials in Miami, Florida.
- Sponsor
- Ardelyx
- Study ID
- NCT02727751
- Phase
- PHASE3
- Status
- Completed
Conditions
- Constipation Predominant Irritable Bowel Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Tenapanor — DRUG
Study Details
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 Dates
- Start date
- Mar 31, 2016
- Status verified
- Aug 2020
- Primary completion
- Oct 31, 2017
- Completion
- Oct 31, 2017
Study Design
- Enrollment
- 312 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 50mg BIDTenapanor, 50 mg BID (100 mg total)
Primary Outcome Measure
Adverse Events in >2% Patients [ Time Frame: 52-55 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ardelyx Clinical Site | Miami | Florida | - | - |
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