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
Results First Received: November 19, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort
Condition: Familial Adenomatous Polyposis (FAP)
Interventions: Drug: Celecoxib
Other: Routine Medical Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study prematurely discontinued in May 2008 prior to reaching planned enrollment target; Last subject last visit November 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Familial Adenomatous Polyposis (FAP) identified subjects=celecoxib-treated and matched control subjects eligible for inclusion in study identified from 4 registry sites; FAP analyzed=celecoxib-treated and matched control subjects eligible for matching and analysis in study. 1 subject excluded from analysis; took celecoxib without a prescription.

Reporting Groups
  Description
Matched Control Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
All Celecoxib Treated All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.

Participant Flow for 2 periods

Period 1:   FAP Identified Subjects
    Matched Control     All Celecoxib Treated  
STARTED     13     55  
COMPLETED     13     54  
NOT COMPLETED     0     1  
Protocol Violation                 0                 1  

Period 2:   FAP Analyzed Subjects
    Matched Control     All Celecoxib Treated  
STARTED     13     54  
COMPLETED     13     51  
NOT COMPLETED     0     3  
Lost to Follow-up                 0                 2  
Other study participation                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Matched Celecoxib Treated Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Matched Control Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Not Matched Celecoxib Treated Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Total Total of all reporting groups

Baseline Measures
    Matched Celecoxib Treated     Matched Control     Not Matched Celecoxib Treated     Total  
Number of Participants  
[units: participants]
  13     13     41     67  
Age, Customized [1]
[units: participants]
       
<25 years     4     5     18     27  
25 to 34 years     5     4     5     14  
35 to 44 years     3     2     8     13  
45 to 54 years     1     1     3     5  
55 to 64 years     0     0     1     1  
>64 years     0     0     0     0  
Age not available (no surgery)     0     1     6     7  
Gender  
[units: participants]
       
Female     2     6     21     29  
Male     11     7     20     38  
[1] Age range groups at most recent FAP-related surgery (years). Prior to start of study follow-up = prior to baseline. Start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and index date for control subjects = baseline.



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Primary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   Time From Start of Study Follow-up to Time of First FAP-related Adverse Event   [ Time Frame: Baseline, Up to 60 months post-baseline ]

9.  Secondary:   Time From Post IRA to Time of Conversion From IRA to IPAA   [ Time Frame: Up to 15 years prior to baseline ]

10.  Secondary:   Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA   [ Time Frame: Baseline, Up to 60 months post-baseline ]

11.  Secondary:   Duodenal Adenoma Burden as Measured by Spigelman Stage   [ Time Frame: Baseline, 6 to 14 months post-baseline, End of study (EOS) ]

12.  Secondary:   Rectal or Pouch Adenoma Burden Based on Polyp Counts   [ Time Frame: Baseline, 6 to 14 months post-baseline, EOS ]

13.  Post-Hoc:   Duodenal Adenoma Burden as Measured by Polyp Counts   [ Time Frame: Baseline, 6 to 14 months post-baseline, End of study (EOS) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


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