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Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP) (CHIP)

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00585312
First received: January 1, 2008
Last updated: October 28, 2014
Last verified: October 2014
Results First Received: October 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Adenomatous Polyposis Coli
Interventions: Drug: Celecoxib
Drug: Placebo

  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
A total of 305 participants were screened, whereof 106 were randomized into the study, and of whom 101 took at least 1 dose of study drug. The clinical study was conducted in 18 centers across 13 countries: Belgium, Czech Republic, Hong Kong, Hungary, Israel, Italy, Slovakia, South Africa, Spain, Sweden, Ukraine, United Kingdom, and United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The randomization was to be stratified by center, age (≥12 years old versus <12 years old), and familial adenomatous polyposis (FAP) phenotype (negative versus positive). The participants were randomized 1:1 to one of the 2 treatments celecoxib or placebo.

Reporting Groups
  Description
Celecoxib Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
Placebo Matching placebo

Participant Flow:   Overall Study
    Celecoxib     Placebo  
STARTED     55 [1]   51 [1]
Treated     53     48  
COMPLETED     4     7  
NOT COMPLETED     51     44  
Adverse Event                 3                 0  
Lack of Efficacy                 6                 11  
Lost to Follow-up                 1                 1  
Reason not specified                 2                 0  
Withdrawal by Subject                 5                 1  
Study terminated by the sponsor                 34                 31  
[1] STARTED=Randomized



  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.
The intent-to-treat (ITT) population (N: 106) consisted of all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether the participants received any study drug or received a different drug from that to which they were randomized.

Reporting Groups
  Description
Celecoxib Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
Placebo Matching placebo
Total Total of all reporting groups

Baseline Measures
    Celecoxib     Placebo     Total  
Number of Participants  
[units: participants]
  55     51     106  
Age  
[units: years]
Mean ± Standard Deviation
  12.6  ± 2.2     12.2  ± 1.8     12.4  ± 2.0  
Gender  
[units: participants]
     
Female     29     28     57  
Male     26     23     49  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Disease Progression   [ Time Frame: 5 years ]

2.  Secondary:   Time to Treatment Failure   [ Time Frame: 5 years ]

3.  Secondary:   Total Number of Colorectal Polyps   [ Time Frame: Years 1 - 5 ]

4.  Secondary:   Colorectal Polyp Burden   [ Time Frame: Years 1 - 5 ]


  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
The study was early terminated and, due to the low number of participants, no efficacy analysis was performed. Only descriptive statistics was performed.


  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.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00585312     History of Changes
Obsolete Identifiers: NCT00393016, NCT00534040
Other Study ID Numbers: A3191193
Study First Received: January 1, 2008
Results First Received: October 28, 2014
Last Updated: October 28, 2014
Health Authority: United States: Food and Drug Administration