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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

Page last updated: August 23, 2015

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