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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)

Primary Purpose

Dysuria

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pílulas de Lussen
Pyridium®
Sponsored by
Laboratorios Osorio de Moraes Ltda.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysuria focused on measuring Pílulas de Lussen, Efficacy, Safety, Dysuria, Symptomatic control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 31, 2009
    Last Updated
    August 31, 2009
    Sponsor
    Laboratorios Osorio de Moraes Ltda.
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    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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