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

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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®

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 Summary: 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.
Sponsor: Laboratorios Osorio de Moraes Ltda.

Current Primary Outcome: Visual Analogic Scale and opinion of the investigator. [ Time Frame: 3 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Of adverse events related to study medication by the Naranjo Algorithm. [ Time Frame: 3 days ]

Original Secondary Outcome: Same as current

Information By: Laboratorios Osorio de Moraes Ltda.

Dates:
Date Received: August 31, 2009
Date Started: December 2009
Date Completion: March 2010
Last Updated: August 31, 2009
Last Verified: August 2009