Clinical trial NCT00151476: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Familial Adenomatous Polyposis (FAP)
Keywords: Familial adenomatous polyposis
celecoxib
IRA
IPAA
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 68
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with FAP

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: 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
Secondary outcomes:
measure: Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas (Duodenal Adenomatous Polyps)
timeFrame: Up to 15 years prior to baseline
measure: Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas
timeFrame: Baseline, Up to 60 months post-baseline
measure: Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event
timeFrame: Up to 15 years prior to baseline
measure: Time From Start of Study Follow-up to Time of First FAP-related Adverse Event
timeFrame: Baseline, Up to 60 months post-baseline
measure: Time From Post IRA to Time of Conversion From IRA to IPAA
timeFrame: Up to 15 years prior to baseline
measure: Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA
timeFrame: Baseline, Up to 60 months post-baseline
measure: Duodenal Adenoma Burden as Measured by Spigelman Stage
timeFrame: Baseline, 6 to 14 months post-baseline, End of study (EOS)
measure: Rectal or Pouch Adenoma Burden Based on Polyp Counts
timeFrame: Baseline, 6 to 14 months post-baseline, EOS
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Hvidovre
country: Denmark
facility: Pfizer Investigational Site
state: Copenhagen
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: