Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00151476

Purpose

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.

Condition	Intervention	Phase
Adenomatous Polyposis Coli	Drug: Celecoxib Other: Routine Medical Care	Phase IV

Study Type:	Observational
Study Design:	Cohort
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

Resource links provided by NLM:

Genetics Home Reference related topics: familial adenomatous polyposis Help Me Understand Genetics

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To evaluate long-term treatment with celecoxib in prolonging the time to FAP-related events [ Time Frame: 3.75 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to first resectional or ablational event for rectal, colonic, pouch, or duodenal adenomas [ Time Frame: 3.75 years ] [ Designated as safety issue: No ]
Duodenal adenoma burden [ Time Frame: 3.75 years ] [ Designated as safety issue: No ]
Time to conversion from IRA to IPAA [ Time Frame: 3.75 years ] [ Designated as safety issue: No ]
Time to FAP-related adverse event [ Time Frame: 3.75 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	72
Study Start Date:	November 2004
Study Completion Date:	May 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Celecoxib 800 mg total daily dosing	Drug: Celecoxib 800 mg total daily dosing
Routine Medical Care - Control Group Observation of subjects treated with routine medical care	Other: Routine Medical Care Observation

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

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with FAP

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151476

Locations

United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G1X5
Denmark, Copenhagen
Pfizer Investigational Site
Hvidovre, Copenhagen, Denmark, DK-2650
Spain
Pfizer Investigational Site
BARCELONA, Spain, 08036

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	NQ4-00-02-012, A3191167
Study First Received:	September 7, 2005
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00151476 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Familial adenomatous polyposis, celecoxib, IRA, IPAA

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Adenomatous Polyposis Coli
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Adenomatous Polyps
Digestive System Neoplasms
Neoplasms by Histologic Type
Intestinal Polyposis

Celecoxib
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Intestinal Diseases
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Genetic Diseases, Inborn
Analgesics, Non-Narcotic
Gastrointestinal Neoplasms
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010