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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-11-30

Study Completion Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Familial Adenomatous Polyposis (FAP)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Celecoxib - Routine Medical Care

800 mg total daily dosing

Celecoxib

Intervention Type DRUG

800 mg total daily dosing

Control Group - Routine Medical Care

Observation of subjects treated with routine medical care

Routine Medical Care

Intervention Type OTHER

Interventions

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Celecoxib

800 mg total daily dosing

Intervention Type DRUG

Routine Medical Care

Intervention Type OTHER

Other Intervention Names

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celebrex, SC-58635

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No