Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01064024 | Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo | PHASE3 | COMPLETED | 233 | — | — | Dec 1, 2009 | Dec 1, 2010 | Jan 29, 2013 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Phenazopyridine Hydrochloride Tablets, USP 200 mg | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | Matching placebo to the phenazopyridine hydrochloride tablets |
| Name | Type | Description |
|---|---|---|
| Phenazopyridine Hydrochloride | DRUG | Tablets, 200 mg, every 8 hours for 48 hours. |
| Placebo | DRUG | Tablets, every 8 hours for 48 hours |
Inclusion Criteria: * Diagnosis of uncomplicated urinary tract infection (uUTI) * Must have one of the following uUTI diagnosis * Cystitis * Urethritis * A Positive urine dipstick test showing nitrate or leukocyte esterase (LE) * Negative pregnancy test (if applicable) * Must have one or both of th...