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

Dysuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657448
• Other study ID #: CYSEMS0112
• Status: Completed
• Phase: Phase 3
• Start date: June 27, 2016
• Est. completion date: December 22, 2017

Study information

• Verified date: July 2020
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: December 22, 2017
• Est. primary completion date: November 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dysuria

Intervention

Drug:
• Methenamine and Methylthioninium chloride
• Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days
• Phenazopyridine
• Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of treatment in the symptomatic relief of dysuria		3 days
Secondary	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