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

Dysuria Clinical Trial

— E01OSMPLS0108  

Official title:

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 Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00969254
• Other study ID #: E01-OSM-PLS-01-08
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 31, 2009
• Last updated: August 31, 2009
• Start date: December 2009
• Est. completion date: March 2010

Study information

• Verified date: August 2009
• Source: Laboratorios Osorio de Moraes Ltda.
• Contact: Dagoberto Brandão
• Phone: 55 11 3673 3763
• Email: dagoberto[@]phcbrasil.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Dysuria

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Osorio de Moraes Ltda.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogic Scale and opinion of the investigator.		3 days	No
Secondary	Of adverse events related to study medication by the Naranjo Algorithm.		3 days	Yes