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Phenazopyridine Tables, USP · 1 trial · 1 indication
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. ...
Phenazopyridine Tablets, USP is used for the short-term treatment of moderate-to-severe pain and burning upon urination in female subjects suffering from uncomplicated urinary tract infections (uUTI). It is an analgesic that provides symptomatic relief of urinary discomfort associated with this condition.
Phenazopyridine Tablets, USP is being developed by Amneal Pharmaceuticals, Inc., a company traded on the New York Stock Exchange under the ticker symbol AMRX. The company is conducting clinical development of this small molecule drug for the treatment of uncomplicated urinary tract infections.
Phenazopyridine Tablets, USP is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 3 trial has been completed, and the drug remains under clinical investigation for its intended use.
Phenazopyridine Tablets, USP has one completed Phase 3 clinical trial, identified as NCT01650051. This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as an analgesic for short-term treatment in female subjects with moderate-to-severe pain and burning upon urination associated with uncomplicated urinary tract infections.
Yes, Phenazopyridine Tablets, USP is the same as Phenazopyridine Hydrochloride Tablets, USP. The clinical trial NCT01650051 specifically evaluated Phenazopyridine Hydrochloride Tablets, USP 200 mg, which is the drug substance in Phenazopyridine Tablets, USP.