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”

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.

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.

Intervention(s) in this Clinical Trial

• Drug: Celecoxib
  • 800 mg total daily dosing
• Other: Routine Medical Care

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA
  • Time Frame: Up to 8 years prior to baseline
    Safety Issue?: No
• Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA
  • Time Frame: Baseline, Up to 60 months post-baseline
    Safety Issue?: No
• Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA
  • Time Frame: Up to 15 years prior to baseline
    Safety Issue?: No
• Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA
  • Time Frame: Baseline, Up to 60 months post-baseline
    Safety Issue?: No

Secondary Measures

• 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)
  • Time Frame: Up to 15 years prior to baseline
    Safety Issue?: No
• Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas
  • Time Frame: Baseline, Up to 60 months post-baseline
    Safety Issue?: No
• Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event
  • Time Frame: Up to 15 years prior to baseline
    Safety Issue?: No
• Time From Start of Study Follow-up to Time of First FAP-related Adverse Event
  • Time Frame: Baseline, Up to 60 months post-baseline
    Safety Issue?: No
• Time From Post IRA to Time of Conversion From IRA to IPAA
  • Time Frame: Up to 15 years prior to baseline
    Safety Issue?: No
• Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA
  • Time Frame: Baseline, Up to 60 months post-baseline
    Safety Issue?: No
• Duodenal Adenoma Burden as Measured by Spigelman Stage
  • Time Frame: Baseline, 6 to 14 months post-baseline, End of study (EOS)
    Safety Issue?: No
• Rectal or Pouch Adenoma Burden Based on Polyp Counts
  • Time Frame: Baseline, 6 to 14 months post-baseline, EOS
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00151476

Study ID Number: NQ4-00-02-012

ClinicalTrials.gov Identifier: NCT00151476

Health Authority: United States: Food and Drug Administration

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