Constipation Predominant Irritable Bowel Syndrome
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGTenapanor
Sponsors
Ardelyx
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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* Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302 * The subject reports using any prohibited medication and is not willing to abide by the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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events in >2% Patients | 52-55 weeks | Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 50mg BID Tenapanor, 50 mg BID (100 mg total) | 312 |
| Total | 312 |
Baseline characteristics
| Characteristic | 50mg BID |
|---|---|
| Age, Continuous | 49.5 years STANDARD_DEVIATION 13.15 |
| Body Mass Index (BMI) | 29.98 kg/m^2 STANDARD_DEVIATION 6.707 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 130 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 182 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 89 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 217 Participants |
| Sex: Female, Male Female | 255 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 312 |
| other Total, other adverse events | 33 / 312 |
| serious Total, serious adverse events | 3 / 312 |
Outcome results
Primary
Adverse Events in >2% Patients
Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams
Time frame: 52-55 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 50mg BID | Adverse Events in >2% Patients | Diarrhea | 33 participants |
| 50mg BID | Adverse Events in >2% Patients | Flatulence | 7 participants |
| 50mg BID | Adverse Events in >2% Patients | Upper Respiratory Tract Infection | 7 participants |
| 50mg BID | Adverse Events in >2% Patients | Headache | 11 participants |