Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients
NCT00151476
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Adult Trials: 18+ Years
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.
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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients | |||
| Official Title | A Registry-Based Observational Study Assessing Clinical Outcomes In Familial Adenomatous Polyposis In Patients Receiving Celecoxib (Celebrex(Registered), Onsenal(Registered)) Compared With Control Patients | |||
| Brief Summary | 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. | |||
| Detailed Description | 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. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Patients with FAP | |||
| Condition | Familial Adenomatous Polyposis (FAP) | |||
| Intervention |
| |||
| Study Groups/Cohorts |
| |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Terminated | |||
| Actual Enrollment | 68 | |||
| Original Enrollment | 200 | |||
| Actual Study Completion Date | November 2008 | |||
| Actual Primary Completion Date | November 2008 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria: Celecoxib Treated Patients:
Historical/Concurrent Control Patients:
Exclusion Criteria: Celecoxib Treated Patients:
Historical/Concurrent Control Patients:
| |||
| Sex/Gender |
| |||
| Ages | 12 Years and older (Child, Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Canada, Denmark, Spain, United States | |||
| Removed Location Countries | Germany | |||
| Administrative Information | ||||
| NCT Number | NCT00151476 | |||
| Other Study ID Numbers | NQ4-00-02-012 A3191167 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2010 | |||