NCT01064024

Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo

A Double Blind, Randomized, Parallel Controlled Study to Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo as a Urinary Analgesic for Short Term Treatment in Female Subjects Suffering From Pain or Burning When Passing Urine Associated With Uncomplicated Urinary Tract Infections (uUTI)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Amneal Pharmaceuticals, LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as a short term analgesic treatment for the primary symptoms of pain or burning when passing urine associated with uncomplicated urinary tract infections (uUTI)

Conditions

• Pain
• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Phenazopyridine Hydrochloride	Tablets, 200 mg, every 8 hours for 48 hours.
DRUG	Placebo	Tablets, every 8 hours for 48 hours

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-02-08
• Last updated: 2013-01-29

Locations

1 site across 1 country: United States