FAMILIAL ADENOMATOUS POLYPOSIS (FAP)
Conditions
Interventions
Product Name: Celebrex / Onsenal
Product Code: SC-58635
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: celecoxib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
PFIZER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of FAP based on genetic predisposition testing 2. Male or female subjects aged 10 to 17 years inclusive at the time of enrollment 3. Subject’s parent or legal guardian has provided written informed consent prior to enrollment in this study 4. Subject has assented to participate prior to enrollment in this study 5. Subject and parent/legal guardian, agree to comply with study requirements and are able to be at the clinic for all required study visits 6. Willingness to abstain from the chronic use of NSAIDs (including aspirin, selective COX-2 inhibitors), oral adrenocorticosteroids, and other nonsteroidal OTC products for the duration of the study. Chronic use of NSAIDs is defined as a frequency of 1 week (7 consecutive days) for more than 3 weeks per year 7. If subject is female and of childbearing potential, she must meet all of the following conditions: • Have been using adequate contraception (e.g. abstinence, condom, IUD, birth control pill, diaphragm and spermicide gel combination) since her last menses AND • Be willing to use adequate contraception (as above) during the study AND • Not be breastfeeding AND • Have a negative urine or serum pregnancy test within 14 days prior to study drug administration 8. The subject will be allowed to proceed to baseline colonoscopy so long as all of the following laboratory criteria are met on Baseline evaluation: • Hemoglobin > 10.0 gm/dl • Platelet count > 100,000/µl • WBC > 3,000/µl • ALT 2mm, visible without dye-enhancement), all must be removed so as to render the colon polyp-free and thus amenable to serial endoscopic surveillance 11. A normal electrocardiogram (ECG) at baseline – Subjects who have an abnormal tracing that is considered not clinically significant by the site investigator may be entered with sponsor approval Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Diagnosis of attenuated FAP 2. History of hypersensitivity to COX-2 inhibitors, sulfonamides, NSAIDs or salicylates 3. Use of any dose of NSAIDs or oral adrenocorticosteroids, at any frequency of 3 or more times per week during the three months prior to study entry will require a three-month washout period beginning with the time of last dose. Use of any dose of NSAIDs or oral adrenocorticosteroids, at any frequency of less than 3 times per week during the three months prior to study entry will require a one-month washout period beginning with the time of last dose. If chronic inhaled steroid use is required, the subject agrees to use mometasone. Use of mometasone is not restricted. In countries were mometasone is not available, only fluticasone will be permitted 4. Anticipated need for concurrent use of fluconazole or lithium 5. Active peptic ulcer disease documented by endoscopy. Significant renal, hepatic or hematologic dysfunction (to be determined by investigator). History of H. pylori related peptic ulcer disease that has been successfully treated with antibiotics will not be exclusionary 6. =20 polyps (> 2 mm without dye enhancement) at baseline colonoscopy 7. 2 mm without dye enhancement) that have not all been removed at baseline colonoscopy 8. Known inability to participate in the scheduled follow-up tests 9. Significant medical or psychiatric problems, which, in the opinion of the site investigator, would make the subject a poor protocol candidate 10. Subject has undergone a colectomy or planned to have colectomy within the next 6 months 11. Subject has undergone chemotherapy within the past 6 months 12. Subject has received pelvic radiation 13. History of invasive carcinoma in the past five years 14. Familial hypercholesterolemia 15. Familial Hypertriglyceridemia 16. Diabetes 17. Coagulopathy 18. Use of any investigational agent within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of celecoxib versus placebo in the prevention and treatment of colorectal polyps growth in young subjects with FAP. Primary Objective: To compare the time from randomization to treatment failure for subjects treated with celecoxib versus subjects treated with placebo, where treatment failure is defined as the earliest occurrence of one or more of the following: a. Appearance of = 20 polyps at any colonoscopy during the study, or b. Diagnosis of colorectal malignancy;Secondary Objective: • To compare the total number of polyps over 5 years for subjects treated with celecoxib versus subjects treated with placebo • To compare polyp burden over 5 years for subjects treated with celecoxib versus subjects treated with placebo • To compare celecoxib with placebo on the time to appearance of = 5 colorectal adenomas for subjects treated with celecoxib versus subjects treated with placebo;Primary end point(s): Time to treatment failure defined as the time • The primary endpoint for this study is time to treatment failure defined as the time from randomization to the earliest occurrence of the following events: a. Appearance of =20 polyps (>2mm, visible without dye enhancement) at any colonoscopy during the study, or b. Diagnosis of colorectal malignancy | — |
Countries
Bulgaria, Czech Republic, Germany, Hungary, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed