Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)
Trial Sites
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Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Prevention | Active | 10 to 17 | Pharmaceutical / Industry | A3191193 MDA-2006-0040, PFIZER-A3191193, N01-CN-05126-2, NCT00393016, NCT00585312 |
Summary
To test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP).
Eligibility Criteria
Inclusion Criteria:
- Age 10-17 years
- Confirmed non-attenuated FAP genotype based on central genetic testing
- Less than 20 polyps, which need to be removed to render the colon polyp-free before study drug can be given
Exclusion Criteria:
- Diagnosis of attenuated FAP based on central genetic testing
- Sensitivity to COX-2 inhibitors
Trial Lead Organizations/Sponsors
Pfizer Incorporated
| Pfizer CT.gov Call Center |  | Study Director |
| Pfizer CT.gov Call Center | | Ph: 1-800-718-1021 |
| Emergingmed | | Ph: 1-877-769-4832 |
| Email: faptrials@emergingmed.com | ||
Trial Sites
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| U.S.A. | |||
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| Michigan | |||
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| Ann Arbor | |||
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| Nebraska | |||
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| Omaha | |||
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| Ohio | |||
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| Chagrin Falls | |||
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| Cincinnati | |||
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| Cleveland | |||
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| Elyria | |||
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| Independence | |||
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| Lakewood | |||
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| Lorain | |||
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| Solon | |||
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| Strongsville | |||
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| Westlake | |||
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| Willoughby Hills | |||
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| Wooster | |||
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| Tennessee | |||
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| Nashville | |||
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| Texas | |||
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| Houston | |||
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| Utah | |||
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| Salt Lake City | |||
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| Belgium | |||
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| Bruxelles | |||
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| Gent | |||
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| Czech Republic | |||
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| Praha | |||
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| Praha 5 | |||
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| Hong Kong | |||
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| Hong Kong | |||
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| Shatin | |||
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| Hungary | |||
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| Miskolc | |||
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| Italy | |||
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| Roma | |||
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| Puerto Rico | |||
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| Rio Piedras | |||
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| Republic of South Africa | |||
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| Cape Town | |||
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| Slovakia | |||
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| Bratislava | |||
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| Spain | |||
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| Madrid | |||
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| Sweden | |||
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| Stockholm | |||
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| Ukraine | |||
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| Donetsk | |||
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| Kyiv | |||
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| United Kingdom | |||
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| England | |||
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| Harrow, Middlesex | |||
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| Pfizer Investigational Site | |||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00585312
Information obtained from ClinicalTrials.gov on December 27, 2011
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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