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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 recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Laboratorios Osorio de Moraes Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Laboratorios Osorio de Moraes Ltda.
ClinicalTrials.gov Identifier:
NCT00969254
First received: August 31, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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 Intervention Phase
Dysuria
 Drug: Pílulas de Lussen
Drug: Pyridium®
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Laboratorios Osorio de Moraes Ltda.:

Primary Outcome Measures:
  • Visual Analogic Scale and opinion of the investigator. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Of adverse events related to study medication by the Naranjo Algorithm. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: December 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969254

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

Sponsors and Collaborators
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 Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP)
  More Information

No publications provided

Responsible Party: Maria Angelina Nardy Mattos, Laboratórios Osório de Moraes Ltda.
ClinicalTrials.gov Identifier: NCT00969254     History of Changes
Other Study ID Numbers: E01-OSM-PLS-01-08
Study First Received: August 31, 2009
Last Updated: August 31, 2009
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Laboratorios Osorio de Moraes Ltda.:
Pílulas de Lussen
Efficacy
Safety
Dysuria
Symptomatic control

Additional relevant MeSH terms:
Dysuria
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013