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Study to Assess the Efficacy and Safety of "P�lulas de Lussen�" Compared to the Pyridium� in the Symptomatic Control of Dysuria

Information source: Laboratorios Osorio de Moraes Ltda.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dysuria

Intervention: Pílulas de Lussen (Drug); Pyridium® (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Laboratorios Osorio de Moraes Ltda.

Official(s) and/or principal investigator(s):
Lúcia Hime, Principal Investigator, Affiliation: Universidade de Santo Amaro (UNISA)
Nabil Ghorayeb, Principal Investigator, Affiliation: Clínica Nabil Ghorayeb
Patrícia Smith, Principal Investigator, Affiliation: Clínica Nabil Ghorayeb
Ceci Lopes, Principal Investigator, Affiliation: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP)

Overall contact:
Dagoberto Brandão, Phone: 55 11 3673 3763, Email: dagoberto@phcbrasil.com.br

Summary

Clinical Study, prospective, comparative, randomized, double-dummy entry with random from a total of 80 patients, 40 patients will receive the test medication (Plulas de Lussen) plus placebo and 40 patients will receive the comparative (Pyridium) plus placebo.

Clinical Details

Official title: Phase III Clinical Study, Prospective, Multicenter, Double-blind, Randomized, Double-dummy to Assess the Efficacy and Safety of "Plulas de Lussen" Compared to the Pyridium in the Symptomatic Control of Dysuria

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Visual Analogic Scale and opinion of the investigator.

Secondary outcome: Of adverse events related to study medication by the Naranjo Algorithm.

Detailed description: Phase III Clinical Study, prospective, multicenter, double-blind, randomized, double-dummy to assess the efficacy and safety of "Plulas 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Dagoberto Brandão, Phone: 55 11 3673 3763, Email: dagoberto@phcbrasil.com.br

Additional Information

Starting date: December 2009
Last updated: August 31, 2009

Page last updated: August 23, 2015

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