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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00969254

Acronym

E01OSMPLS0108

Enrollment

Registered

2009-09-01

Start date

2009-12-31

Completion date

2010-03-31

Last updated

2009-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysuria

Keywords

Pílulas de Lussen, Efficacy, Safety, Dysuria, Symptomatic control

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.

Interventions

DRUGPílulas 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.

DRUGPyridium®

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Visual Analogic Scale and opinion of the investigator.	3 days

Secondary

Measure	Time frame
Of adverse events related to study medication by the Naranjo Algorithm.	3 days

Contacts

Primary ContactDagoberto Brandão

dagoberto@phcbrasil.com.br55 11 3673 3763

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026