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Efficacy Study of Methenamine + Methylthioninium Chloride vs Phenazopyridine for the Symptomatic Control of Dysuria

NCT01657448 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2020-07-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of the combination of Methenamine + Methylthioninium chloride compared to phenazopyridine (comparator product) in the symptomatic relief of dysuria.

Conditions

  • Dysuria

Interventions

DRUG

Methenamine and Methylthioninium chloride

• Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days

DRUG

Phenazopyridine

• Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days

Sponsors & Collaborators

  • EMS

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-27
Primary Completion
2016-11-21
Completion
2017-12-22

Countries

  • Brazil

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 NCT01657448 on ClinicalTrials.gov