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

NCT01064024 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2013-01-29

No results posted yet for this study

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

Interventions

DRUG

Phenazopyridine Hydrochloride

Tablets, 200 mg, every 8 hours for 48 hours.

DRUG

Placebo

Tablets, every 8 hours for 48 hours

Sponsors & Collaborators

  • Oxford Pharmaceutical Resources, Inc.

    collaborator INDUSTRY

  • Sristek Clinical Research Solutions Limited

    collaborator INDUSTRY

  • Biostudy Solutions, LLC

    collaborator UNKNOWN

  • 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
2009-12-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01064024 on ClinicalTrials.gov