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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 (E01OSMPLS0108)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00969254
Recruitment Status : Unknown
Verified August 2009 by Laboratorios Osorio de Moraes Ltda..
Recruitment status was:  Not yet recruiting
First Posted : September 1, 2009
Last Update Posted : September 1, 2009
Sponsor:
Information provided by:
Laboratorios Osorio de Moraes Ltda.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dysuria Drug: Pílulas de Lussen Drug: Pyridium® Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2009
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analogic Scale and opinion of the investigator. [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. Of adverse events related to study medication by the Naranjo Algorithm. [ Time Frame: 3 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969254


Contacts
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Contact: Dagoberto Brandão 55 11 3673 3763 dagoberto@phcbrasil.com.br

Sponsors and Collaborators
Laboratorios Osorio de Moraes Ltda.
Investigators
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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 Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP)
More Information
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Responsible Party: Maria Angelina Nardy Mattos, Laboratórios Osório de Moraes Ltda.
ClinicalTrials.gov Identifier: NCT00969254    
Other Study ID Numbers: E01-OSM-PLS-01-08
First Posted: September 1, 2009    Key Record Dates
Last Update Posted: September 1, 2009
Last Verified: August 2009
Keywords provided by Laboratorios Osorio de Moraes Ltda.:
Pílulas de Lussen
Efficacy
Safety
Dysuria
Symptomatic control
Additional relevant MeSH terms:
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Dysuria
Lower Urinary Tract Symptoms
Urological Manifestations