Status:
UNKNOWN
Study to Assess the Efficacy and Safety of "Pílulas de Lussen®" Compared to the Pyridium® in the Symptomatic Control of Dysuria
Lead Sponsor:
Laboratorios Osorio de Moraes Ltda.
Conditions:
Dysuria
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 contro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00969254
Start Date
December 1 2009
End Date
March 1 2010
Last Update
September 1 2009
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