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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Constipation Predominant Irritable Bowel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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50mg BID

Tenapanor, 50 mg BID (100 mg total)

Group Type EXPERIMENTAL

Tenapanor

Intervention Type DRUG

Interventions

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Tenapanor

Intervention Type DRUG

Other Intervention Names

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RDX5791 AZD1722

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No