A Registry-Based Observational Study Assessing Clinical Outcomes In Familial Adenomatous Polyposis In Patients Receiving Celecoxib (Celebrex(Registered), Onsenal(Registered)) Compared With Control Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA
研究概览
简要总结
This is a registry-based observational study assessing clinical outcomes in FAP patients receiving celecoxib compared with historical/concurrent registry patients who have not received celecoxib.
Both retrospective and prospective data will be utilized. No sampling methods apply.
详细描述
The study prematurely discontinued on April 11, 2008 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Celecoxib Treated Patients:
- •Diagnosis of FAP based on the expression of the FAP phenotype.
- •Celecoxib treatment prescribed outside of a clinical trial setting with expected duration of celecoxib treatment of at least six months.
- •Historical/Concurrent Control Patients:
- •Diagnosis of FAP based on the expression of the FAP phenotype.
- •Be greater than or equal to 12 years old at the time of study enrollment.
- •Have an endoscopically assessable colonic, rectal, ileal pouch and/or gastroduodenal segment.
- •For the group of post-surgical patients, IRA or IPAA performed from 1985 onward (in order to assure standardized surgical techniques and post-surgical management). Patients whose primary colorectal surgery was performed prior to 1985 will not be eligible to serve as historical controls.
排除标准
- •Celecoxib Treated Patients:
- •Have received a pharmacological treatment (other than celecoxib) within the last 3 months for their FAP disease including treatment of any extracolonic manifestation of FAP.
- •Have received a non-steroidal anti-inflammatory drug (NSAID) within the last 3 months, other than celecoxib, for any reason.
- •Historical/Concurrent Control Patients:
- •Have pharmacological treatment recorded for their FAP disease at the defined index date.
- •Have received a non-steroidal anti-inflammatory drug (NSAID) within the last 3 months for any reason.
研究组 & 干预措施
Celecoxib - Routine Medical Care
800 mg total daily dosing
干预措施: Celecoxib (Drug)
Control Group - Routine Medical Care
Observation of subjects treated with routine medical care
干预措施: Routine Medical Care (Other)
结局指标
主要结局
Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA
时间窗: Up to 8 years prior to baseline
Time(months): \[date of first excisional polypectomy of rectal polyp post IRA minus date of prior IRA plus 1\] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient's most recent FAP-related surgery date=index date for Matched Control.
Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA
时间窗: Baseline, Up to 60 months post-baseline
Time(months): \[date of first excisional polypectomy of rectal polyp post IRA minus date of start of study follow-up plus 1\] divided by 30.44.
Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA
时间窗: Up to 15 years prior to baseline
Time (months): \[date of first excisional polypectomy of a rectal polyp post IPAA minus date of prior IPAA plus 1\] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient's most recent FAP-related surgery date=index date for Matched Control.
Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA
时间窗: Baseline, Up to 60 months post-baseline
Time (months): \[date of first excisional polypectomy of rectal polyp post IPAA minus date of start of study follow-up plus 1\] divided by 30.44.
次要结局
- Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas (Duodenal Adenomatous Polyps)(Up to 15 years prior to baseline)
- Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas(Baseline, Up to 60 months post-baseline)
- Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event(Up to 15 years prior to baseline)
- Time From Start of Study Follow-up to Time of First FAP-related Adverse Event(Baseline, Up to 60 months post-baseline)
- Time From Post IRA to Time of Conversion From IRA to IPAA(Up to 15 years prior to baseline)
- Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA(Baseline, Up to 60 months post-baseline)
- Duodenal Adenoma Burden as Measured by Spigelman Stage(Baseline, 6 to 14 months post-baseline, End of study (EOS))
- Rectal or Pouch Adenoma Burden Based on Polyp Counts(Baseline, 6 to 14 months post-baseline, EOS)