drugset / Trial / 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)

NCT01650051

Phase 3 Completed 424 enrolled Amneal Pharmaceuticals, LLC Symbio, LLC · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2012-02
Primary completion
2013-02
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Phenazopyridine Small molecule 200 mg