Study to Assess the Efficacy and Safety of "Pílulas de Lussen®" Compared to the Pyridium® in the Symptomatic Control of Dysuria (E01OSMPLS0108)

Laboratorios Osorio de Moraes

Status and phase: Unknown; Phase 3

Conditions: Dysuria

Treatments: Drug: Pílulas de Lussen; Drug: Pyridium®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00969254

E01-OSM-PLS-01-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Pílulas de Lussen

Experimental group

Description:

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.

Treatment:

Drug: Pílulas de Lussen

Pyridium®

Active Comparator group

Description:

Take one dragee of drug A\* and one dragee of drug B\*\* every 8 hours for three days. \* Drug A: Pyridium® \*\* Drug B: placebo.

Treatment:

Drug: Pyridium®