Coxib-inhibition of Duodenal Polyp Growth in FAP
Information source: Oslo University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Duodenal Polyposis
Intervention: Rofecoxib (Drug); placebo (Drug)
Phase: Phase 2/Phase 3
Status: Terminated
Sponsored by: Oslo University Hospital
Summary
Preliminary data indicate a protective effect on the development of duodenal polyps by coxib
treatment. The hypothesis of the present study is that normal therapy doses of rofecoxib
for 1 year would stop or reverse the development of premalignant adenomatous lesions in the
duodenal mucosa of FAP patients.
Clinical Details
Official title: Coxib-inhibition of Duodenal Polyp Growth in Familial Adenomatous Polyposis
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- FAP patient with previous colectomy and confirmed polyposis
Exclusion Criteria:
- Pregnancy
- Malignancy
- NSAID hypersensitivity
Locations and Contacts
Dept of Medicine, Rikshospitalet, Oslo 0027, Norway
Additional Information
Starting date: September 2003
Last updated: July 3, 2011
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