Coxib-inhibition of Duodenal Polyp Growth in FAP | oneFAPvoice

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terminated

Coxib-inhibition of Duodenal Polyp Growth in FAP

study id #: NCT00844727

condition: Duodenal Polyposis

status: Terminated

purpose:

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.

intervention:
Drug: Rofecoxib
Drug: placebo

start date: September 2003

estimated completion: April 2004

last updated: July 6, 2011

phase of development: Phase 2, Phase 3

size / enrollment: 38

study design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

inclusion criteria:
- FAP patient with previous colectomy and confirmed polyposis

exclusion criteria:
- Pregnancy
- Malignancy
- NSAID hypersensitivity

sponsor: Oslo University Hospital

locations: Norway