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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

September 7, 2005
March 4, 2010
November 2004
November 2008   (final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT00151476 on ClinicalTrials.gov Archive Site
  • 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).
Not Provided
Not Provided
Not Provided
 
Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients
A Registry-Based Observational Study Assessing Clinical Outcomes In Familial Adenomatous Polyposis In Patients Receiving Celecoxib (Celebrex(Registered), Onsenal(Registered)) Compared With Control Patients

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.

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.

Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

Patients with FAP

Familial Adenomatous Polyposis (FAP)
  • Drug: Celecoxib
    800 mg total daily dosing
    Other Name: celebrex, SC-58635
  • Other: Routine Medical Care
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
68
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Denmark,   Spain
 
NCT00151476
NQ4-00-02-012, A3191167
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP