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

NCT ID: NCT00969254

Last Updated: 2009-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-03-31

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.

Conditions

Dysuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pílulas de Lussen

Intervention Type: DRUG

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®

Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days.

• Drug A: Pyridium®

** Drug B: placebo.

Group Type: ACTIVE_COMPARATOR

Pyridium®

Intervention Type: DRUG

Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days.

• Drug A: Pyridium®

** Drug B: placebo.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorios Osorio de Moraes Ltda.

INDUSTRY

Sponsor Role: lead

Responsible Party

Laboratórios Osório de Moraes Ltda.

Principal Investigators

Lúcia Hime

Role: PRINCIPAL_INVESTIGATOR

Universidade de Santo Amaro (UNISA)

Nabil Ghorayeb

Role: PRINCIPAL_INVESTIGATOR

Clínica Nabil Ghorayeb

Patrícia Smith

Role: PRINCIPAL_INVESTIGATOR

Clínica Nabil Ghorayeb

Ceci Lopes

Role: PRINCIPAL_INVESTIGATOR

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP)

Central Contacts

Dagoberto Brandão

Role: CONTACT

dagoberto@phcbrasil.com.br

55 11 3673 3763

Other Identifiers

E01-OSM-PLS-01-08

Identifier Type: -

Identifier Source: org_study_id