Status:
TERMINATED
Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients
Lead Sponsor:
Pfizer
Conditions:
Familial Adenomatous Polyposis (FAP)
Eligibility:
All Genders
12+ years
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. Bot...
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00151476
Start Date
November 1 2004
End Date
November 1 2008
Last Update
September 4 2024
Active Locations (4)
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1
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
2
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G1X5
3
Pfizer Investigational Site
Hvidovre, Copenhagen, Denmark, DK-2650
4
Pfizer Investigational Site
Barcelona, Spain, 08036