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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Familial Adenomatous Polyposis (FAP)

Intervention: Celecoxib (Drug); Routine Medical Care (Other)

Phase: Phase 4

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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 design: Observational Model: Cohort

Primary outcome:

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

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

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

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

Secondary outcome:

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 From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas

Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event

Time From Start of Study Follow-up to Time of First FAP-related Adverse Event

Time From Post IRA to Time of Conversion From IRA to IPAA

Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA

Duodenal Adenoma Burden as Measured by Spigelman Stage

Rectal or Pouch Adenoma Burden Based on Polyp Counts

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

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, Barcelona 08036, Spain

Pfizer Investigational Site, Hvidovre, Copenhagen DK-2650, Denmark

Pfizer Investigational Site, Cleveland, Ohio 44195, United States

Pfizer Investigational Site, Toronto, Ontario M5G1X5, Canada

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: November 2004
Last updated: March 4, 2010

Page last updated: August 20, 2015

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