Study to Assess the Efficacy and Safety of Pílulas de Lussen® Compared to the Pyridium® in the Symptomatic Control of Dysuria

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Dysuria

Intervention / Treatment
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* Drug: Pílulas de Lussen
* Drug: Pyridium®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over the age of 18 years; Patients with symptoms of dysuria characterized by pain/burning sensation in the lower urinary tract and discomfort in urination; Patients who are female and are of childbearing age should use reliable method of contraception and have negative pregnancy test. Patients who consent to participate in the study. Exclusion Criteria: Patients with sensitivity to any component of the formula; Patients pregnant or lactating; Patients with a history of glaucoma, heart failure, cardiac arrhythmias, prostatic hypertrophy, paralytic ileus or pyloric stenosis; Patients with menorrhagia or heavy menstrual periods; Patients who need to use antibiotics or chemotherapy; Patients who can not follow the procedures shown in this Clinical Protocol.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pílulas de Lussen<br>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. | Drug: Pílulas de Lussen<br>* 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.<br>|
| Active Comparator: Pyridium®<br>Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days. * Drug A: Pyridium® ** Drug B: placebo. | Drug: Pyridium®<br>* Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days. * Drug A: Pyridium® ** Drug B: placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogic Scale and opinion of the investigator. |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Of adverse events related to study medication by the Naranjo Algorithm. |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pílulas de Lussen, Efficacy, Safety, Dysuria, Symptomatic control