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

Phase 3

Completed

• Conditions: Dysuria
• Interventions: Drug: Methenamine and Methylthioninium chloride; Drug: Phenazopyridine

• Registration Number: NCT01657448
• Lead Sponsor: EMS

Brief 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.

Study Timeline

• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-03
• Study First Posted: 2012-08-06
• Study Start: 2016-06-27
• Primary Completion: 2016-11-21
• Study Completion: 2017-12-22
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

Inclusion Criteria

• Patients who agree to participate by agreeing to the terms proposed in the Clinical trial;
• Patients aged over 18 years of any ethnicity;
• Presence of dysuria with marking greater than or equal to 5 measured points on the categorical scale pre-treatment for pain symptom;

Exclusion Criteria

• Patients who are febrile (axillary T º: ≥ 38 ° C), with back pain or lumbar;
• Patients with complicated clinical presentation of urinary tract infection;
• Patients with a history of allergy or intolerance to any known or suspected one of the ingredients of the product under investigation;
• Patients who are pregnant or during lactation, or childbearing potential and are not making use of effective contraception;
• Patients presenting with renal disease or severe liver disease, according to medical history and / or laboratory;
• Patients presenting with severe systemic disease according to the known medical history;
• Patients who received antibiotic treatment, anthelmintic within 7 days prior to study entry;
• Patients unable to understand the guidelines specified in this protocol or can not attend all study visits or unable to complete the log;
• Pregnancy or risk of pregnancy and lactating patients;
• Any finding of clinical observation (history and physical examination) that is interpreted by the physician investigator as a risk to the patient's participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methenamine, Methylthioninium	Methenamine and Methylthioninium chloride	-
Phenazopyridine	Phenazopyridine	-

Primary Outcome Measures

Name	Time	Method
Efficacy of treatment in the symptomatic relief of dysuria	3 days

Secondary Outcome Measures

Name	Time	Method
Safety of the study medication	7 days	To assess the safety of the study medication on the occurrence, type, intensity and frequency of adverse reactions during the treatment period.

Trial Locations

Locations (4)

Marcio Antonio Pereira Clinica de Endocrinologia; 🇧🇷 São José dos Campos, São Paulo, Brazil

Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

AFIP; 🇧🇷 São Paulo, Brazil

Savmed Clinica Médica S/C Ltda.; 🇧🇷 São Paulo, Brazil