Coxib-inhibition of Duodenal Polyp Growth in FAP

Phase 2

Terminated

• Conditions: Duodenal Polyposis
• Interventions: Drug: Rofecoxib; Drug: placebo

• Registration Number: NCT00844727
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Status Verified: 2009-02
• Study First Submitted: 2009-02-13
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-16
• Last Update Submitted: 2011-07-03
• Last Update Posted: 2011-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• FAP patient with previous colectomy and confirmed polyposis

Exclusion Criteria

• Pregnancy
• Malignancy
• NSAID hypersensitivity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rofecoxib	Rofexocib 25 mg OD, 1 year treatment
2	placebo	Placebo

Trial Locations

Locations (1)

Dept of Medicine, Rikshospitalet; 🇳🇴 Oslo, Norway