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

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

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.

Study Overview

• Status: Unknown
• Conditions: Dysuria
• Intervention / Treatment: Drug: Pílulas de Lussen; Drug: Pyridium®

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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: 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.
ACTIVE_COMPARATOR: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Analogic Scale and opinion of the investigator.	3 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Of adverse events related to study medication by the Naranjo Algorithm.	3 days

Collaborators and Investigators

• Sponsor: Laboratorios Osorio de Moraes Ltda.
• Investigators: Principal Investigator: Lúcia Hime, Universidade de Santo Amaro (UNISA); Principal Investigator: Nabil Ghorayeb, Clínica Nabil Ghorayeb; Principal Investigator: Patrícia Smith, Clínica Nabil Ghorayeb; Principal Investigator: Ceci Lopes, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP)

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ANTICIPATED): February 1, 2010
• Study Completion (ANTICIPATED): March 1, 2010

Study Registration Dates

• First Submitted: August 31, 2009
• First Submitted That Met QC Criteria: August 31, 2009
• First Posted (ESTIMATE): September 1, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 1, 2009
• Last Update Submitted That Met QC Criteria: August 31, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Dysuria; Pílulas de Lussen; Symptomatic control
• Additional Relevant MeSH Terms: Lower Urinary Tract Symptoms; Urological Manifestations; Dysuria
• Other Study ID Numbers: E01-OSM-PLS-01-08