drugset / Trial / NCT01657448

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

NCT01657448

Phase 3 Completed 316 enrolled EMS
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Methenamine Unknown 250 mg Oral
Subject Methylene Blue Diagnostic / imaging agent 20 mg Oral
Comparator Phenazopyridine Small molecule 100 mg Oral

Indications