None listed
Conditions
Interventions
Group 1 Type of group
Celecoxib, 400 mg PO QD (2 X 200 mg QD) por 37 meses
Group name:Group 2 Type of group
Placebo, PO QD (2 X Placebo QD) for 37 months
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subject must have a documented colonoscopy of the blind man (documented by means of a photograph) made by a physician related to the study with adequate preparation, resulting in the diagnosis and clearance of an adenomatous polyp within a period of 4 months (120 days) before randomization (90 days between the colonoscopy and the Initial period). 2. In the basal colonoscopy, the subject must have one of the following requirements, documented: A. An adenomatous polyp> 6 mm; confirmed by the colonoscopy report and documented B. Two or more adenomatous polyps (up to a maximum of 10) of any size documented by a local pathology laboratory report plus the colonoscopy report. C. If the colonoscopy report indicates that any polyp of any size was left in the subject, the subject is not eligible. D. If the colonoscopy report does not specifically indicate that all visible adenomas were removed, but does not describe that any adenoma may have been left inside, the subject is eligible if it meets the criteria of A or B. 3. The subject must be 30 years of age or older. 4. The subject is willing to abstain from the chronic use of all NSAIDs or COX-2 inhibitors, excluding aspirin at cardiovascular doses of 3 weeks a year or more than 21 days throughout the year. 5. The duration of the anticipated use of oral / endovenous corticosteroids by the subject throughout the 6-month period should be less than 2 weeks. 6. The anticipated use of orally inhaled steroids by the subject over a period of 6 months should be less than 4 weeks. If the chronic use of inhaled steroids nasally is necessary, the subject should commit to using mometasone (Nasonex®). The use of mometasone is not restricted. In countries where mometasone (Nasonex®) is not available, fluticasone (Flonase®) will only be allowed. Subjects can be switched to mometasone, but they must have discontinued the previous nasal steroid for at least 30 days before randomization. The change must be made during or before the Initial Placebo visit. 7. If the subject is female or is of childbearing age (it is considered that women are not of childbearing age if they are at least 2 years post-menopausal and / or surgically sterile): A. they must have been using adequate methods of contraception (abstinence, IUD, birth control pills or spermicidal gel with diaphragm or condom) since their last menstrual period and should use adequate methods of contraception during the study. B. should not be lactating, and should have a negative pregnancy test before Randomization. 8. The subject must sign and date the informed consent document, which must be obtained before carrying out any procedure related to the study. 9. The subject must meet the following laboratory eligibility criteria for a period not to exceed 45 days before enrollment in the randomization period: A. Hemoglobin level greater than 11.0 g / dl (women) or 11.5 g / dl (men) B. White blood cell count greater than 3000 / mm ^ C. Platelet count greater than 125,000 / mm ^ D. Creatinine <1.5 X ULN E. AST <2.0 X ULN, ALT <2.0 X ULN F. Total bilirubin <1.5 X ULN excluding Gilbert´s disease.
Exclusion criteria
Exclusion criteria: 1. The subject has had a history of familial adenomatous polyposis or non-hereditary polyposis colorectal cancer 2. The subject has a history of inflammatory bowel disease. 3. The subject has chronic or acute renal or hepatic impairment, a significant alteration of hemorrhages, or any other condition that in the opinion of the investigator prevents their participation in the study throughout the duration of the trial. 4. The subject has a history of hypersensitivity to COX-2 inhibitors, NSAIDs, salicylates or sulfonamides. 5. Subject has a history of resection of the large intestine excluding appendectomy. 6. The subject has used NSAIDs, excluding aspirin at a cardiovascular dose (eg, <162.5 mg PO per day or 325 mg interdiario), at a frequency equal to or greater than three times a week during the two months (60 days) prior to randomization. 7. The subject has received treatment for gastrointestinal ulcer in the month prior to the Initial stage. 8. The subject has a history of invasive cancer during the past five years (excluding non-melanoma skin cancer). 9. Subject has received an investigational medication within 30 days prior to randomization or is scheduled to receive an investigational drug other than celecoxib during the course of the study. 10. The subject can not return for visits and follow-up tests. 11. The subject is currently using fluconazole or lithium. 12. The subject participated in the study previously and was withdrawn. 13. The subject has previously taken celecoxib or any other COX-2 inhibitor at a frequency greater than 3 times per week in a period of 2 months (60 days) prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:it will be estimated using the life table method for each treatment group in Year 1 and Year 3 and compared using an extension of the Mantel-Haenszel statistics life table with stratification for the use of aspirin. Measure:Proportion of subjects with new adenomas Timepoints:In Year 1 and Year 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The total number of adenomas and the highest histopathological grade of the adenomas will be recorded and analyzed using ordinal categorical data analysis methods. Measure:Number of colorectal adenomas, their size and degree Timepoints:In Year 1 and Year 3 | — |
Countries
Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kindgdom, United States, Uruguay
Outcome results
None listed