NCT00026468撤回2 期
Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
研究概览
简要总结
RATIONALE: Exisulind may be effective in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.
PURPOSE: Randomized phase II/III trial to determine the effectiveness of exisulind in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.
详细描述
OBJECTIVES:
- Determine the ability of exisulind to inhibit growth and development of duodenal adenomas in patients with familial adenomatous polyposis.
- Determine the effect on apoptosis in polyp vs mucosal tissue in these patients when treated with this drug.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral exisulind 4 times daily.
- Arm II: Patients receive oral placebo 4 times daily. Treatment continues for 1 year.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •One of the following diagnosis:
- •Diagnosis of familial adenomatous polyposis
- •Prior total or subtotal colectomy
- •Attenuated adenomatous polyposis coli
- •May have colon intact
- •10-40 duodenal polyps from second portion to 10 cm distal to papilla of Vater
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Hemoglobin at least 10 g/dL
- •Platelet count at least 100,000/mm^3
- •No active hematologic disease
- •AST and ALT less than 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase less than 1.5 times ULN
- •No active hepatic disease
- •Creatinine less than 1.5 mg/dL
- •No active renal disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active peptic ulcer disease
- •No serious underlying medical or psychiatric illness that would preclude completion of the study or limit survival
- •No prisoners or institutionalized patients
- •No known allergy to sulindac or related compounds
- •No active internal malignancy within the past 5 years
- •No alcohol or drug abuse within the past 5 years
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •See Disease Characteristics
- •No prior non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates more than 10 days a month for the past 3 months
- •No concurrent NSAIDs (e.g., mesalamine, olsalazine, azodisalicylate, salsalate, sulfasalazine)
- •Aspirin for cardiac reasons allowed (81 mg/day or 325 mg twice/week)
排除标准
- 未提供
研究者
相似试验
终止
2 期
Coxib-inhibition of Duodenal Polyp Growth in FAPDuodenal PolyposisNCT00844727Oslo University Hospital38
终止
3 期
Celecoxib in Preventing Polyps in Patients Who Have Undergone Surgery for Stage I Colon CancerColorectal CancerNCT00087256NSABP Foundation Inc18
已完成
2 期
Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous PolyposisDuodenal NeoplasmsDuodenal PolypsFamilial Adenomatous PolyposisNCT00808743Radboud University Medical Center37
Unknown
2 期
Niclosamide for Familial Adenomatous PolyposisFamilial Adenomatous PolyposisNCT04296851Yonsei University72
终止
3 期
Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)Adenomatous Polyposis ColiNCT00585312Pfizer's Upjohn has merged with Mylan to form Viatris Inc.106