NCT01657448

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

Phase III, Prospective, Multicenter, Single-blind, Randomized, Superiority to Evaluate the Efficacy and Safety of Methenamine Association 250mg + Methylthioninium Chloride 20 mg Compared to Phenazopyridine 100 mg in Symptomatic Control of Dysuria

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: EMS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* Single blind, randomized, prospective study. * Length of experience: 03 days to 07 days. * 03 visits (days 1, 4 and 7). * Evaluation of the efficacy and safety of the medication. * Shall be assessed for adverse events.

Conditions

• Dysuria

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-06-27
• Primary completion: 2016-11-21
• Completion: 2017-12-22
• First posted: 2012-08-06
• Last updated: 2020-07-07

Locations

4 sites across 1 country: Brazil