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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methenamine, Methylthioninium | Experimental |
| |
| Phenazopyridine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methenamine and Methylthioninium chloride | Drug | • Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of treatment in the symptomatic relief of dysuria | 3 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda | Porto Alegre | Rio Grande do Sul | Brazil | |||
| Marcio Antonio Pereira Clinica de Endocrinologia |
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| ID | Term |
|---|---|
| D053159 | Dysuria |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008709 | Methenamine |
| D008751 | Methylene Blue |
| D010621 | Phenazopyridine |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000218 | Adamantane |
| D001952 |
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| Phenazopyridine | Drug | • Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days |
|
|
| São José dos Campos |
| São Paulo |
| Brazil |
| AFIP | São Paulo | Brazil |
| Savmed Clinica Médica S/C Ltda. | São Paulo | Brazil |
| Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |