Efficacy Study of Methenamine + Methylthioninium

Efficacy Study of Methenamine + Methylthioninium Chloride vs
Phenazopyridine for the Symptomatic Control of Dysuria
Status: Not yet recruiting
Study Phase: Phase 3
Start Date: January 2016 | Completion Date: October 2016
Condition(s): Dysuria
Full Title of Study
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
Overview
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.
Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study,
Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary
Purpose: Treatment
Investigator Details
Lead Sponsor: EMS
Trial Location Details
Facility: Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda Porto Alegre, Brazil
Facility: UNISA Santo Amaro, Brazil
Facility: Marcio Antonio Pereira Clinica de Endocrinologia São José dos Campos, Brazil
Facility: AFIP São Paulo, Brazil
Facility: Savmed Clinica Médica S/C Ltda. São Paulo, Brazil
Facility: Sociedade de atendimento Cardiológico LTDA São Paulo, Brazil
Principal Investigator: Patrícia Smith, MD
Facility: USP São Paulo, Brazil
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
Information Source
ID Number: CYSEMS0112
NCT Identifier: NCT01657448
Health Authority: Brazil: National Health Surveillance Agency
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT01657448
ClinicalTrials.gov processed this data on September 30, 2016
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately
by this site. Please see the full source link above for retrieving further details from the government database.