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This is a multi-center, Phase 2, randomized, double-blind, placebo controlled study of RDX5791 in subjects with IBS-C. Patients who are 18 to 75 years old, meeting the definition of IBS-C as defined by the Rome III Criteria for the Diagnosis of IBS will undergo a battery of screening procedures to determine eligibility for the trial.
The study will consist of a 2-week treatment-free screening period, a 4-week blinded treatment period, and a 2-week treatment-free follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Capsule that is identical in size and color to other treatments |
|
| Low Dose | Experimental | 10 mg capsule of tenapanor |
|
| Mid Dose | Experimental | 30 mg capsule of tenapanor |
|
| High Dose | Experimental | 100 mg capsule of tenapanor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDX5791 | Drug | Capsule, QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline | Patients complete a phone diary daily. They are asked "how many bowel movements have you had today?" they are then asked for each spontaneous bowel movement (unaided with laxative use) wether there was its was a complete evacuation. if it was then it is a complete spontaneous bowel movement. All CSBMs are added and adjusted for a mean compete sponteneous bowel movement. | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous Bowel Movement (SBM) Frequency Change From Baseline | baseline and week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David P Rosenbaum, Ph.D. | Ardelyx | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ardelyx Investigational Site | San Diego | California | 92108 | United States | ||
| Ardelyx Investigational Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Capsule, QD |
| FG001 | 10mg | RDX5791: Capsule, QD |
| FG002 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Jupiter |
| Florida |
| 33458 |
| United States |
| Ardelyx Investigational Site | Pinellas Park | Florida | 33782 | United States |
| Ardelyx Investigational Site | Rockford | Illinois | 61107 | United States |
| Ardelyx Investigational Site | Mission | Kansas | 66202 | United States |
| Ardelyx Investigational Site | Monroe | Louisiana | 71201 | United States |
| Ardelyx Investigational Site | Annapolis | Maryland | 21401 | United States |
| Ardelyx Investigational Site | Chesterfield | Michigan | 48047 | United States |
| Ardelyx Investigational Site | St Louis | Missouri | 63128 | United States |
| Ardelyx Investigational Site | Brooklyn | New York | 11214 | United States |
| Ardelyx Investigational Site | Greensboro | North Carolina | 27408 | United States |
| Ardelyx Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| Ardelyx Investigational Site | Simpsonville | South Carolina | 29681 | United States |
| Ardelyx Investigational Site | Bristol | Tennessee | 37620 | United States |
| Ardelyx Investigational Site | Ogden | Utah | 84405 | United States |
| Ardelyx Investigational Site | Lynchburg | Virginia | 24502 | United States |
| 30 mg |
RDX5791: Capsule, QD |
| FG003 | 100 mg | RDX5791: Capsule, QD |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | RDX5791: Capsule, QD |
| BG001 | Low Dose | RDX5791: Capsule, QD |
| BG002 | Mid Dose | RDX5791: Capsule, QD |
| BG003 | High Dose | RDX5791: Capsule, QD |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline | Patients complete a phone diary daily. They are asked "how many bowel movements have you had today?" they are then asked for each spontaneous bowel movement (unaided with laxative use) wether there was its was a complete evacuation. if it was then it is a complete spontaneous bowel movement. All CSBMs are added and adjusted for a mean compete sponteneous bowel movement. | All patients randomized who received at least one dose of drug | Posted | Mean | Standard Deviation | number of bowel movements/week | Baseline and Week 4 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Spontaneous Bowel Movement (SBM) Frequency Change From Baseline | Posted | Mean | Standard Deviation | change in number of bowel movements | baseline and week 4 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | RDX5791: Capsule, QD | 0 | 47 | 0 | 47 | 0 | 47 |
| EG001 | Low Dose | RDX5791: Capsule, QD | 0 | 46 | 2 | 46 | 0 | 46 |
| EG002 | Mid Dose | RDX5791: Capsule, QD | 0 | 47 | 0 | 47 | 0 | 47 |
| EG003 | High Dose | RDX5791: Capsule, QD | 0 | 46 | 0 | 46 | 0 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cholecystitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| appendicitis | Gastrointestinal disorders | Systematic Assessment |
|
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Publications must be reviewed and approved by sponsor
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Development Officer | Ardelyx | 510 745 1752 | drosenbaum@ardelyx.com |
| ID | Term |
|---|---|
| C000599417 | tenapanor |
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| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
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| More than one race |
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| Unknown or Not Reported |
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|