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

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.

Study Overview

• Status: Completed
• Conditions: Dysuria
• Intervention / Treatment: Drug: Methenamine and Methylthioninium chloride; Drug: Phenazopyridine

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 Type: Interventional
• Enrollment (Actual): 316
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • AFIP
  • São Paulo, Brazil
    • Savmed Clinica Médica S/C Ltda.
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda
  • São Paulo
    • São José dos Campos, São Paulo, Brazil
      • Marcio Antonio Pereira Clinica de Endocrinologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Methenamine, Methylthioninium	Drug: Methenamine and Methylthioninium chloride; • Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days
Active Comparator: Phenazopyridine	Drug: Phenazopyridine; • Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days; Other Names: Pyridium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of treatment in the symptomatic relief of dysuria	3 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2016
• Primary Completion (Actual): November 21, 2016
• Study Completion (Actual): December 22, 2017

Study Registration Dates

• First Submitted: August 2, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (Estimate): August 6, 2012

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Symptom of Dysuria
• Additional Relevant MeSH Terms: Lower Urinary Tract Symptoms; Urological Manifestations; Dysuria; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Anti-Infective Agents, Urinary; Renal Agents; Methylene Blue; Methenamine; Methenamine hippurate; Methenamine mandelate
• Other Study ID Numbers: CYSEMS0112