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Clinical Study, prospective, comparative, randomized, double-dummy entry with random from a total of 80 patients, 40 patients will receive the test medication (Pílulas de Lussen®) plus placebo and 40 patients will receive the comparative (Pyridium®) plus placebo.
Phase III Clinical Study, prospective, multicenter, double-blind, randomized, double-dummy to assess the efficacy and safety of "Pílulas de Lussen®" compared to the Pyridium® in the symptomatic control of dysuria in 80 patients of either sex or race, older than 18 years, with symptoms of dysuria, 40 patients will receive the test medication (Pílulas de Lussen®) plus placebo and 40 patients will receive the comparative (Pyridium®) plus placebo to evaluate the effectiveness and tolerability of 'Pílulas de Lussen' for symptomatic relief of dysuria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pílulas de Lussen | Experimental | Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days. * Drug A: Pílulas de Lussen® ** Drug B: placebo. |
|
| Pyridium® | Active Comparator | Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days. * Drug A: Pyridium® ** Drug B: placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pílulas de Lussen | Drug | Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days. * Drug A: Pílulas de Lussen® ** Drug B: placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogic Scale and opinion of the investigator. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Of adverse events related to study medication by the Naranjo Algorithm. | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dagoberto Brandão | Contact | 55 11 3673 3763 | dagoberto@phcbrasil.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Lúcia Hime | Universidade de Santo Amaro (UNISA) | Principal Investigator |
| Nabil Ghorayeb | Clínica Nabil Ghorayeb | Principal Investigator |
| Patrícia Smith |
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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 |
|---|---|
| D010621 | Phenazopyridine |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Pyridium® | Drug | Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days. * Drug A: Pyridium® ** Drug B: placebo. |
|
| Clínica Nabil Ghorayeb |
| Principal Investigator |
| Ceci Lopes | Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) | Principal Investigator |