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

• Status: Unknown status
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Osorio de Moraes Ltda.

Criteria

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.