Trial record 12 of 45 for:    Familial Adenomatous Polyposis

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

This study has been terminated.
(See Detailed Description)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00151476
First received: September 7, 2005
Last updated: March 4, 2010
Last verified: March 2010
  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
Familial Adenomatous Polyposis (FAP)
Drug: Celecoxib
Other: Routine Medical Care
Phase 4

Study Type: Observational
Study Design: Observational Model: 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:


Further study details as provided by Pfizer:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome 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 ] [ Designated as safety issue: No ]
    Time (months): [date of first excisional or ablational event for colonic, pouch, or duodenal adenomas occuring after date of most recent prior FAP-related surgical event or date of FAP diagnosis minus date of most recent prior FAP-related surgical event or date of FAP diagnosis plus 1] divided by 30.44.

  • 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 ] [ Designated as safety issue: No ]
    Time (months): [date of first excisional or ablational event for colonic, pouch, or duodenal adenomas, occurring after date of most recent prior FAP-related surgical event, or date of FAP diagnosis minus date of start of study follow-up plus 1] divided by 30.44.

  • 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 ] [ Designated as safety issue: No ]
    Time (months): [date of first FAP-related adverse event, occurring after the date of most recent prior FAP-related surgery, or date of FAP diagnosis minus date of most recent prior FAP-related surgery, or date of FAP diagnosis plus 1] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).

  • Time From Start of Study Follow-up to Time of First FAP-related Adverse Event [ Time Frame: Baseline, Up to 60 months post-baseline ] [ Designated as safety issue: No ]
    Time (months): [date of first FAP-related adverse event, occurring after the date of the most recent prior FAP-related surgery, or date of FAP diagnosis minus date of start of study follow-up plus 1] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).

  • Time From Post IRA to Time of Conversion From IRA to IPAA [ Time Frame: Up to 15 years prior to baseline ] [ Designated as safety issue: No ]
    Time (months): [date of IPAA minus date of prior IRA plus 1] divided by 30.44.

  • Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA [ Time Frame: Baseline, Up to 60 months post-baseline ] [ Designated as safety issue: No ]
    Time (months): [date of IPAA minus date of start of study follow-up plus 1] divided by 30.44.

  • Duodenal Adenoma Burden as Measured by Spigelman Stage [ Time Frame: Baseline, 6 to 14 months post-baseline, End of study (EOS) ] [ Designated as safety issue: No ]
    Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: Spigelman stage provides index of disease severity based on number of polyps, polyp size, histology, and dysplasia; range is Stage 0 (none) to Stage IV (severe). EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline). Spigelman Stage not completed as staging data largely missing; see measure: Duodenal adenoma burden as measured by polyp counts.

  • Rectal or Pouch Adenoma Burden Based on Polyp Counts [ Time Frame: Baseline, 6 to 14 months post-baseline, EOS ] [ Designated as safety issue: No ]
    Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: attenuated: <100 polyps, mild: between 100 to 1000 polyps, severe: >1000 polyps. EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline).


Enrollment: 68
Study Start Date: November 2004
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Celecoxib - Routine Medical Care
800 mg total daily dosing
Drug: Celecoxib
800 mg total daily dosing
Other Name: celebrex, SC-58635
Control Group - Routine Medical Care
Observation of subjects treated with routine medical care
Other: Routine Medical Care

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:

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.
  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
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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00151476     History of Changes
Other Study ID Numbers: NQ4-00-02-012, A3191167
Study First Received: September 7, 2005
Results First Received: November 19, 2009
Last Updated: March 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Familial adenomatous polyposis
celecoxib
IRA
IPAA

Additional relevant MeSH terms:
Adenomatous Polyposis Coli
Adenomatous Polyps
Intestinal Polyposis
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Genetic Diseases, Inborn
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014