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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2014-06-26

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Symbio, LLC

    collaborator INDUSTRY

  • Amneal Pharmaceuticals, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01650051 on ClinicalTrials.gov