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

Last updated on February 22, 2020

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Study Location
Pfizer Investigational Site
Cleveland, Ohio, 44195 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Familial Adenomatous Polyposis (FAP)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00151476
Pfizer
Terminated
Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients

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Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with FAP
Condition Familial Adenomatous Polyposis (FAP)
Intervention
  • Drug: Celecoxib
    800 mg total daily dosing
    Other Name: celebrex, SC-58635
  • Other: Routine Medical Care
Study Groups/Cohorts
  • Celecoxib - Routine Medical Care
    800 mg total daily dosing
    Intervention: Drug: Celecoxib
  • Control Group - Routine Medical Care
    Observation of subjects treated with routine medical care
    Intervention: Other: Routine Medical Care
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: February 12, 2010)
68
Original Enrollment
 (submitted: September 8, 2005)
200
Actual Study Completion Date November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   Denmark,   Spain,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number NCT00151476
Other Study ID Numbers NQ4-00-02-012
A3191167
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2010

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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