A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C
| Status: | Recruiting |
|---|---|
| Conditions: | Constipation, Irritable Bowel Syndrome (IBS) |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | March 2016 |
| End Date: | December 2017 |
| Contact: | Lisa Salisbury |
| Email: | Lisa.Salisbury@iconplc.com |
An Open Label Long-Term Safety Study of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (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.
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.
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.
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.
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
We found this trial at
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