Trial | NCT00969254  Report issue

Title

Study to Assess the Efficacy and Safety of "Pílulas de Lussen®" Compared to the Pyridium® in the Symptomatic Control of Dysuria
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    80
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.
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.
Study Started
Dec 31
2009
Primary Completion
Feb 28
2010
Anticipated
Study Completion
Mar 31
2010
Anticipated
Last Update
Sep 01
2009
Estimate

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.

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.

Pílulas de Lussen Experimental

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.

Pyridium® Active Comparator

Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days. * Drug A: Pyridium® ** Drug B: placebo.

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.
No Results Posted