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)

A Double-Blind, Randomized, Multi-Center, Parallel-Group, Placebo-Controlled Study to Evaluate the 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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 424 (actual)
• Sponsor: Amneal Pharmaceuticals, LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the safety and efficacy of Phenazopyridine HCl Tablets, USP 200 mg as a short term analgesic treatment of pain upon urination associated with Uncomplicated Urinary Tract Infections (uUTI). The secondary exploratory objective is to evaluate safety and efficacy of Phenazopyridine HCl Tablets, USP 200 mg as a short term analgesic treatment of burning upon urination associated with uUTI.

Detailed description

Subjects will make separate self-assessments for severity of pain and burning upon urination using the NRS and self-assessments of their discomfort using the GSAS at designated intervals for 24 hours. Subjects will rate the effectiveness of the study medication using the SASMS at a designated interval for 24 hours.

Conditions

• Uncomplicated Urinary Tract Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-02-01
• Completion: 2014-02-01
• First posted: 2012-07-26
• Last updated: 2014-06-26

Locations

1 site across 1 country: United States