Study to Assess the Efficacy and Safety of "Pílulas de Lussen®" Compared to the Pyridium® in the Symptomatic Control of Dysuria (E01OSMPLS0108)
Primary Purpose
Dysuria
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pílulas de Lussen
Pyridium®
Sponsored by
About this trial
This is an interventional treatment trial for Dysuria focused on measuring Pílulas de Lussen, Efficacy, Safety, Dysuria, Symptomatic control
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pílulas de Lussen
Pyridium®
Arm Description
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.
Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days. * Drug A: Pyridium® ** Drug B: placebo.
Outcomes
Primary Outcome Measures
Visual Analogic Scale and opinion of the investigator.
Secondary Outcome Measures
Of adverse events related to study medication by the Naranjo Algorithm.
Full Information
NCT ID
NCT00969254
First Posted
August 31, 2009
Last Updated
August 31, 2009
Sponsor
Laboratorios Osorio de Moraes Ltda.
1. Study Identification
Unique Protocol Identification Number
NCT00969254
Brief Title
Study to Assess the Efficacy and Safety of "Pílulas de Lussen®" Compared to the Pyridium® in the Symptomatic Control of Dysuria
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
March 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Laboratorios Osorio de Moraes Ltda.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysuria
Keywords
Pílulas de Lussen, Efficacy, Safety, Dysuria, Symptomatic control
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pílulas de Lussen
Arm Type
Experimental
Arm Description
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.
Arm Title
Pyridium®
Arm Type
Active Comparator
Arm Description
Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days.
* Drug A: Pyridium®
** Drug B: placebo.
Intervention Type
Drug
Intervention Name(s)
Pílulas de Lussen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pyridium®
Intervention Description
Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days.
* Drug A: Pyridium®
** Drug B: placebo.
Primary Outcome Measure Information:
Title
Visual Analogic Scale and opinion of the investigator.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Of adverse events related to study medication by the Naranjo Algorithm.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dagoberto Brandão
Phone
55 11 3673 3763
Email
dagoberto@phcbrasil.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lúcia Hime
Organizational Affiliation
Universidade de Santo Amaro (UNISA)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nabil Ghorayeb
Organizational Affiliation
Clínica Nabil Ghorayeb
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrícia Smith
Organizational Affiliation
Clínica Nabil Ghorayeb
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ceci Lopes
Organizational Affiliation
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study to Assess the Efficacy and Safety of "Pílulas de Lussen®" Compared to the Pyridium® in the Symptomatic Control of Dysuria
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