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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01650051 | Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as an Analgesic for Short-Term Treatment in Female Subjects Suffering From Moderate-to-Severe Pain and Burning Upon Urination Associated With Uncomplicated Urinary Tract Infections (uUTI) | PHASE3 | COMPLETED | 424 | — | — | Feb 1, 2012 | Feb 1, 2014 | Jun 26, 2014 | 1 | United States |
The difference between baseline NRS for pain at 0 hours and the NRS for pain score at each scheduled time will be calculated to obtain Pain Intensity Difference (PID) at each time point 92, 4, 6, 8, 16 and 24.
| Arm | Type | Description |
|---|---|---|
| Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg | PLACEBO_COMPARATOR | - |
| Phenazopyridine Hydrochloride Tables, USP 200 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg | DRUG | Deep brown maroon colored, film coated round biconvex tablet debossed 'AN" obve '2' on one side and plain on the other side. |
| Phenazopyridine Hydrochloride Tables, USP 200 mg | DRUG | Deep brown maroon colored, film coated round biconvex tablet debossed 'AN" obve '2' on one side and plain on the other side. |
Inclusion Criteria: * Is willing and able to provide and understand written informed consent for the study. * Is a female 18 years of age or older. * Has a clinical diagnosis of uncomplicated urinary tract infection (uUTI). * Has a reported history indicating a diagnosis of cystitis or urethritis. ...