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Coxib-inhibition of Duodenal Polyp Growth in FAP

Coxib-inhibition of Duodenal Polyp Growth in Familial Adenomatous Polyposis

Status
Terminated
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00844727
Enrollment
38
Registered
2009-02-16
Start date
2003-09-30
Completion date
2004-04-30
Last updated
2011-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duodenal Polyposis

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.

Interventions

DRUGplacebo

placebo pills

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* FAP patient with previous colectomy and confirmed polyposis

Exclusion criteria

* Pregnancy * Malignancy * NSAID hypersensitivity

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026