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

Phase 3

• Conditions: Dysuria
• Interventions: Drug: Pílulas de Lussen; Drug: Pyridium®

• Registration Number: NCT00969254
• Lead Sponsor: Laboratorios Osorio de Moraes Ltda.

Brief Summary

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

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.

Study Timeline

• Status Verified: 2009-08
• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-08-31
• Last Update Submitted: 2009-08-31
• Study First Posted: 2009-09-01
• Last Update Posted: 2009-09-01
• Study Start: 2009-12
• Primary Completion: 2010-02
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pílulas de Lussen	Pílulas de Lussen	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®	Pyridium®	Take one dragee of drug A\* and one dragee of drug B\*\* every 8 hours for three days. \* Drug A: Pyridium® \*\* Drug B: placebo.

Primary Outcome Measures

Name	Time	Method
Visual Analogic Scale and opinion of the investigator.	3 days

Secondary Outcome Measures

Name	Time	Method
Of adverse events related to study medication by the Naranjo Algorithm.	3 days