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

NCT00969254 | Unknown Phase 3

• 1 other identifier: E01-OSM-PLS-01-08
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dysuria

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Visual Analogic Scale and opinion of the investigator.

  3 days

Secondary Outcomes (1)

• Of adverse events related to study medication by the Naranjo Algorithm.

  3 days

Study Arms (2)

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.

Drug: Pílulas de Lussen

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.

Drug: Pyridium®

Interventions

Pílulas de Lussen DRUG

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.

Pílulas de Lussen

Pyridium® DRUG

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

Pyridium®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios Osorio de Moraes Ltda.: lead

MeSH Terms

Conditions

Dysuria

Interventions

Phenazopyridine

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lúcia Hime

  Universidade de Santo Amaro (UNISA)

  PRINCIPAL INVESTIGATOR

• Nabil Ghorayeb

  Clínica Nabil Ghorayeb

  PRINCIPAL INVESTIGATOR

• Patrícia Smith

  Clínica Nabil Ghorayeb

  PRINCIPAL INVESTIGATOR

• Ceci Lopes

  Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dagoberto Brandão

CONTACT

55 11 3673 3763; dagoberto@phcbrasil.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 1, 2009
• Study Start: December 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 1, 2009

Record last verified: 2009-08