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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-27

Study Completion Date

2017-12-22

Brief Summary

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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.

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Detailed Description

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* 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.

Conditions

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Dysuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Methenamine, Methylthioninium

Group Type EXPERIMENTAL

Methenamine and Methylthioninium chloride

Intervention Type DRUG

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

Phenazopyridine

Group Type ACTIVE_COMPARATOR

Phenazopyridine

Intervention Type DRUG

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

Interventions

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Methenamine and Methylthioninium chloride

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

Intervention Type DRUG

Phenazopyridine

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

Intervention Type DRUG

Other Intervention Names

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Pyridium

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No