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Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.
Open-label long-term safety study of tenapanor in pediatric patients with IBS-C. Eligible patients who complete the parent study will have an option to enroll in this study.
Patients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg BID or 25 mg BID per guidance in protocol after a patient's first week on the assigned dose. Patients will also return for study visits approximately every 6 weeks for safety assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenapanor | Experimental | Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg BID or 25 mg BID per Investigator guidance after a patient's first week on the assigned dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenapanor | Drug | Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study. Doses can be titrated to either 50 mg BID or 25 mg BID |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Measure Assessment (Adverse Event) | Incidence of AEs, SAEs and drug related adverse events | 40 weeks |
| Safety Measure Assessment (ECG) | Descriptive summaries of ECG parameters (heart rate, PR-interval, QRS-duration, QT-interval, QTc-interval, and RR-interval) | 40 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jocelyn Tabora | Ardelyx | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| G & L Research, LLC | Foley | Alabama | 36535 | United States | ||
| Advanced Research Center, Inc. |
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Open label study
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|
| Anaheim |
| California |
| 92805 |
| United States |
| Prohealth Research Center | Doral | Florida | 33166 | United States |
| I.H.S. Health, LLC | Kissimmee | Florida | 34741 | United States |
| Valencia Medical and Research Center | Miami | Florida | 33165 | United States |
| Orlando Health, Inc.- APH Center for Digestive Health and Nutrition | Orlando | Florida | 32806 | United States |
| Florida Pharmaceutical Research and Associates, Inc. | South Miami | Florida | 33143 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Riley Children's Health | Indianapolis | Indiana | 46202 | United States |
| Maine Health | Portland | Maine | 04102 | United States |
| Mankato Clinic/ Javara Research Ltd | Mankato | Minnesota | 56001 | United States |
| Boys Town National Research Hospital | Boys Town | Nebraska | 68010 | United States |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| Advantage Clinical Trials | The Bronx | New York | 10467 | United States |
| Atrium Health | Charlotte | North Carolina | 28203 | United States |
| Duke University School of Medicine | Durham | North Carolina | 27705 | United States |
| Wilmington Health | Wilmington | North Carolina | 28401 | United States |
| Frontier Clinical Research, LLC | Scottdale | Pennsylvania | 15683 | United States |
| Frontier Clinical Research, LLC | Smithfield | Pennsylvania | 15478 | United States |
| Prisma Health Children's Hospital | Greenville | South Carolina | 29615 | United States |
| Advance Clinical Trial PLLC | Abilene | Texas | 79606 | United States |
| Maspons Pediatric Gastro | El Paso | Texas | 79902 | United States |
| Texas Digestive Specialists | Harlingen | Texas | 78550 | United States |
| AIM Trials, LLC | Plano | Texas | 75093 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
| Pioneer Research Solutions Inc | Sugar Land | Texas | 77479 | United States |
| Frontier Clinical Research | Kingwood | West Virginia | 26537 | United States |
| ID | Term |
|---|---|
| C000599417 | tenapanor |
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