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NCT02727751 · ClinicalTrials.gov registry record · Phase 3
A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C
A Phase 3 study, sponsored by Ardelyx.
- Completed
- Registry status
- Phase 3
- Development phase
- 312
- Enrollment target
NCT02727751 is a Phase 3 study that has completed, run by Ardelyx. The registered enrollment target is 312 participants.
The verdict
NCT02727751, a Phase 3 study, has completed, sponsored by Ardelyx.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 312 participants
- Enrollment target
Study 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.
Interventions
- DRUG Tenapanor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2016-03 |
| Est. Completion | 2017-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02727751
The ClinicalTrials.gov registry entry for NCT02727751 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 312 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ardelyx, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tenapanor is the first listed.
NCT02727751 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02727751 about?
NCT02727751 is a clinical study titled "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. Subje...
What is the current status of trial NCT02727751?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 312 participants. The study started on 2016-03. Estimated completion is 2017-10.
What interventions are being tested in trial NCT02727751?
The interventions under investigation include: Tenapanor (DRUG).
Who is sponsoring clinical trial NCT02727751?
This trial is sponsored by Ardelyx, which has 25 total clinical trials registered on ClinicalTrials.gov.
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