TerminatedNot Applicable

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

Stopped: See Detailed Description

United States, Canada, Denmark68 participantsStarted 2004-11

Plain-language 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.

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA

Timeframe: Up to 8 years prior to baseline

Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA

Timeframe: Baseline, Up to 60 months post-baseline

Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA

Timeframe: Up to 15 years prior to baseline

Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA

Timeframe: Baseline, Up to 60 months post-baseline

Trial details

NCT IDNCT00151476

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2008-11

Results submitted2009-11-19

View on ClinicalTrials.gov More Familial Adenomatous Polyposis (FAP) trials

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA

Timeframe: Up to 8 years prior to baseline

Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA

Timeframe: Baseline, Up to 60 months post-baseline

Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA

Timeframe: Up to 15 years prior to baseline

Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA

Timeframe: Baseline, Up to 60 months post-baseline