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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Dysuria

Intervention / Treatment
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* Drug: Methenamine and Methylthioninium chloride
* Drug: Phenazopyridine


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptom of Dysuria