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

NCT00151476 | Terminated Results

• 2 other identifiers: NQ4-00-02-012A3191167
• Study Type: observational
• Target: 68
• Locations: 4 countries
• Sites: 4

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.

Conditions

Familial Adenomatous Polyposis (FAP)

Keywords

Familial adenomatous polyposis; celecoxib; IRA; IPAA

Outcome Measures

Primary Outcomes (4)

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

  Time(months): \[date of first excisional polypectomy of rectal polyp post IRA minus date of prior IRA plus 1\] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient's most recent FAP-related surgery date=index date for Matched Control.

  Up to 8 years prior to baseline

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

  Time(months): \[date of first excisional polypectomy of rectal polyp post IRA minus date of start of study follow-up plus 1\] divided by 30.44.

  Baseline, Up to 60 months post-baseline

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

  Time (months): \[date of first excisional polypectomy of a rectal polyp post IPAA minus date of prior IPAA plus 1\] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient's most recent FAP-related surgery date=index date for Matched Control.

  Up to 15 years prior to baseline

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

  Time (months): \[date of first excisional polypectomy of rectal polyp post IPAA minus date of start of study follow-up plus 1\] divided by 30.44.

  Baseline, Up to 60 months post-baseline

Secondary Outcomes (8)

• 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)

  Up to 15 years prior to baseline

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

  Baseline, Up to 60 months post-baseline

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

  Up to 15 years prior to baseline

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

  Baseline, Up to 60 months post-baseline

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

  Up to 15 years prior to baseline

Study Arms (2)

Celecoxib - Routine Medical Care

800 mg total daily dosing

Drug: Celecoxib

Control Group - Routine Medical Care

Observation of subjects treated with routine medical care

Other: Routine Medical Care

Interventions

Celecoxib DRUG

800 mg total daily dosing

Also known as: celebrex, SC-58635

Celecoxib - Routine Medical Care

Routine Medical Care OTHER

Control Group - Routine Medical Care

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with FAP

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Pfizer Investigational Site

Cleveland, Ohio, 44195, United States

Location

Pfizer Investigational Site

Toronto, Ontario, M5G1X5, Canada

Location

Pfizer Investigational Site

Hvidovre, Copenhagen, DK-2650, Denmark

Location

Pfizer Investigational Site

Barcelona, 08036, Spain

Location

Related Links

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

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Study prematurely discontinued May 2008 prior to reaching enrollment target; due to limited number of matched pairs, results do not provide sufficient data to evaluate effectiveness of celecoxib. Last subject last visit was November 2008.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: November 1, 2004
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: September 4, 2024
• Results First Posted: March 4, 2010

Record last verified: 2024-08

Locations

US (1); DK (1); ES (1); CA (1)