Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients

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Pfizer

Status

Terminated

Conditions

Familial Adenomatous Polyposis (FAP)

Treatments

Other: Routine Medical Care
Drug: Celecoxib

Study type

Observational

Funder types

Industry

Identifiers

NCT00151476
NQ4-00-02-012
A3191167

Details and patient eligibility

About

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.

Full 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.

Enrollment

68 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.

Trial design

68 participants in 2 patient groups

Celecoxib - Routine Medical Care
Description:
800 mg total daily dosing
Treatment:
Drug: Celecoxib
Control Group - Routine Medical Care
Description:
Observation of subjects treated with routine medical care
Treatment:
Other: Routine Medical Care

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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