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)

PHASE3CompletedINTERVENTIONAL
Enrollment

424

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

February 28, 2013

Study Completion Date

February 28, 2014

Conditions
Uncomplicated Urinary Tract Infections
Interventions
DRUG

Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg

"Deep brown maroon colored, film coated round biconvex tablet debossed 'AN obve '2' on one side and plain on the other side."

DRUG

Phenazopyridine Hydrochloride Tables, USP 200 mg

"Deep brown maroon colored, film coated round biconvex tablet debossed 'AN obve '2' on one side and plain on the other side."

Trial Locations (1)

11777

Symbio, LLC, Port Jefferson

Sponsors
All Listed Sponsors
collaborator

Symbio, LLC

INDUSTRY

lead

Amneal Pharmaceuticals, LLC

INDUSTRY