None listed
Conditions
Interventions
It will be administered with placebo rofecoxib 25 mg / day for six years.
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: a. The patient is a male person> 50 years old and 6 years b. The patient has a PSA in the selection (Visit 1)> 2.5 ng / mL and 4 ng / mL and <10 ng / mL and a normal biopsy (no evidence of malignancy or prosthetic intraepithelial neoplasia) High grade - minor grades are accepted - within the 1st year of selection (Visit 1). Reports and pathology sheets should be sent for central reading and evaluation. c. The patient underwent a digital rectal examination within 4 weeks of the selection (Visit 1) that did NOT indicate signs of malignancy.
Exclusion criteria
Exclusion criteria: a. The patient has active, uncontrolled hypertension (diastolic blood pressure when sitting> 95 mm Hg or systolic blood pressure when sitting> 165 mm Hg). Patients with medically controlled hypertension can participate. b. The patient has congestive heart failure with symptoms that are present at rest or with minimal activity. c. The patient has unstable angina - angina that occurs at rest or with minimum activity. d. The patient has had a history of stroke or attack transient ischemic disease (TIA), myocardial infarction, coronary angioplasty percutaneous transluminal, or coronary artery graft within 6 months of the selection (Visit 1). e. The patient suffers, regardless of the etiology, malabsorption gastrointestinal clinic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body contracted with the Use of the SPONSOR product, which is considered or not related to the use of the product. Any endeavor (ie, any clinically significant adverse change in frequency and / or intensity) of a preexisting condition that is temporarily associated with the use of the SPONSOR product is also considered an adverse event. Measure:Evaluation and registration of adverse effects Timepoints:3 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The cumulative percentage of patients who develop extracapsular prostate cancer Measure:The cumulative percentage of patients who develop extracapsular prostate cancer will be lower in patients treated with rofecoxib 25 mg / day than in patients treated with placebo. Timepoints:3 month | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Greece, Israel, Italy, Netherlands, New Zealand, Portugal, Singapore, Sweden, Switzerland, United Kindgdom, United States, Venezuela
Outcome results
None listed