Coxib-inhibition of Duodenal Polyp Growth in FAP

Duodenal Polyposis Clinical Trial

Official title:

Coxib-inhibition of Duodenal Polyp Growth in Familial Adenomatous Polyposis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00844727
• Other study ID #: RH01/01
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: February 13, 2009
• Last updated: July 3, 2011
• Start date: September 2003
• Est. completion date: April 2004

Study information

• Verified date: February 2009
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• FAP patient with previous colectomy and confirmed polyposis

Exclusion Criteria:

• Pregnancy

• Malignancy

• NSAID hypersensitivity

Study Design

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

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Duodenal Polyposis

Intervention

Drug:
• Rofecoxib

• placebo
placebo pills

Locations

Country	Name	City	State
Norway	Dept of Medicine, Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway,