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

NCT00969254 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2009-09-01

No results posted yet for this study

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.

Conditions

  • Dysuria

Interventions

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.

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.

Sponsors & Collaborators

  • Laboratorios Osorio de Moraes Ltda.

    lead INDUSTRY

Principal Investigators

  • Lúcia Hime · Universidade de Santo Amaro (UNISA)

  • Nabil Ghorayeb · Clínica Nabil Ghorayeb

  • Patrícia Smith · Clínica Nabil Ghorayeb

  • Ceci Lopes · Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-02-28
Completion
2010-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00969254 on ClinicalTrials.gov