Clinical trial NCT00969254: Study to Assess the Efficacy and Safety of "Pílulas de Lussen®" Compared to the Pyridium® in the Symptomatic Control of Dysuria
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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dysuria
Keywords: Pílulas de Lussen
Efficacy
Safety
Dysuria
Symptomatic control
Lead sponsor: Laboratorios Osorio de Moraes Ltda.
Sponsor class: INDUSTRY
First posted: 2009-09-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analogic Scale and opinion of the investigator.
timeFrame: 3 days
Secondary outcomes:
measure: Of adverse events related to study medication by the Naranjo Algorithm.
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
affiliation: Universidade de Santo Amaro (UNISA)
name: Lúcia Hime
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Nabil Ghorayeb
name: Nabil Ghorayeb
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Nabil Ghorayeb
name: Patrícia Smith
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP)
name: Ceci Lopes
role: PRINCIPAL_INVESTIGATOR
References: