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NCT00969254: E01OSMPLS0108

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 Phase 3 Last updated 31 August 2009
What this trial tests

Phase 3 trial testing Pílulas de Lussen in Dysuria in 80 participants. Status unknown.

Timeline
1 December 2009
Primary endpoint
1 February 2010
1 March 2010

Quick facts

Lead sponsorLaboratorios Osorio de Moraes Ltda.
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment80
Start date1 December 2009
Primary completion1 February 2010
Estimated completion1 March 2010

Drugs / interventions tested

Conditions studied

Sponsor

Laboratorios Osorio de Moraes Ltda. — full company profile →

Who can join

18 and older, any sex, with Dysuria. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing