EUCTR2012-000427-41-GB进行中（未招募）1 期
A Double-Blind, Randomized, Phase III Trial of the Safety and Efficacy of CPP-1X/Sulindac Compared With CPP-1X, Sulindac as Single Agents in Patients with Familial Adenomatous Polyposis (FAP)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 171
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subjects (male and female), = 18 years
- •2. Diagnosis of genotypic and/or phenotypic FAP or AFAP with disease involvement of the duodenum and/or colon/rectum/pouch.
- •o Genotype: APC mutation
- •o Classical FAP Phenotype: 100’s to 1,000’s of colorectal adenomatous polyps, usually appearing in teenage years
- •3. Patients with an intact colon/rectum and prophylactic surgery is being considered as a stratification site.
- •4. Rectal/pouch polyposis as a stratification site as follows: At least three years since colectomy/proctocolectomy with IRA or pouch, and demonstrating polyposis as defined by Stage 1,2,3 of proposed InSiGHT staging system.
- •5. Duodenal polyposis as a stratification site; one or more of the following: Current Spigelman Stage 3 or 4. Prior surgical endoscopic intervention within the past six months for Spigelman Stage 3 or 4 that may have been down staged to Spigelman 1 or 2.
- •6. Absence of major cardiac risk factors.
- •7. Absence of clinically significant hearing loss requiring a hearing aid.
- •8. Adequate laboratory studies (hematology, chemistry, and urinalysis) at study entry.
- •9. If female, neither pregnant nor lactating.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 172
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior pelvic irradiation
- •2. Patients receiving oral corticosteroids within 30 days of enrolment
- •3. Treatment with other investigational agents within the prior 4 weeks
- •4. Use of other non-steroidal anti-inflammatory drugs (such as ibuprofen) exceeding 4 days per month, in the prior 6weeks
- •5. Regular use of aspirin in excess of 700mg per week
- •6. Treatment with other FAP directed drug therapy (including sulindac or celecoxib, fish oil) within 12 weeks of study enrollment.
- •7. Hypersensitivity to cyclooxygenase-2 inhibitors, sulfonamides, NSAIDs, or salicylates; NSAID associated symptoms of gastritis.
- •8. Patients at high cardiovascular disease risk are not eligible for study participation as defined below.
- •Uncontrolled high blood pressure (systolic blood pressure >150 mm hg;.
- •Unstable angina;
- •History of documented myocardial infarction or cerebrovascular accident;
- •New York Heart Association Class III or IV heart failure;
- •Known uncontrolled hyperlipidemia defined as LDL-C = 190 mg/dL or triglycerides = 500 mg/dL;
- •9. Patients with significant hearing loss are not eligible for study participation as defined below.
- •? Hearing loss that affects everyday life and/or for which a hearing aid is required.
- •10. Intact colon/rectum or retained rectum or ileal pouch:
- •a) cancer on biopsy
- •b)high grade dysplasia found on polyp biopsy where the polyp is not completely removed
- •c)a large polyp (>1cm) not completely removed
- •11. Duodenal cancer on biopsy.
- •12. Intra-abdominal desmoid disease, stage III or IV.
研究者
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