NCT00969254

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Laboratorios Osorio de Moraes Ltda. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysuria

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-02-01
• Completion: 2010-03-01
• First posted: 2009-09-01
• Last updated: 2009-09-01