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

NCT01657448 | Completed Phase 3 DMC

• 1 other identifier: CYSEMS0112
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 4

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.

Conditions

Dysuria

Keywords

Symptom of Dysuria

Outcome Measures

Primary Outcomes (1)

• Efficacy of treatment in the symptomatic relief of dysuria

  3 days

Secondary Outcomes (1)

• Safety of the study medication

  7 days

Study Arms (2)

Methenamine, Methylthioninium

EXPERIMENTAL

Drug: Methenamine and Methylthioninium chloride

Phenazopyridine

ACTIVE COMPARATOR

Drug: Phenazopyridine

Interventions

Methenamine and Methylthioninium chloride DRUG

• Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days

Methenamine, Methylthioninium

Phenazopyridine DRUG

• Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days

Also known as: Pyridium

Phenazopyridine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

Study Sites (4)

Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda

Porto Alegre, Rio Grande do Sul, Brazil

Location

Marcio Antonio Pereira Clinica de Endocrinologia

São José dos Campos, São Paulo, Brazil

Location

AFIP

São Paulo, Brazil

Location

Savmed Clinica Médica S/C Ltda.

São Paulo, Brazil

Location

MeSH Terms

Conditions

Dysuria

Interventions

Methenamine; Methylene Blue; Phenazopyridine

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 6, 2012
• Study Start: June 27, 2016
• Primary Completion: November 21, 2016
• Study Completion: December 22, 2017
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

BR (4)