Coxib-inhibition of Duodenal Polyp Growth in FAP

University of Oslo (UIO)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Duodenal Polyposis

Treatments: Drug: placebo; Drug: Rofecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT00844727

RH01/01

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• FAP patient with previous colectomy and confirmed polyposis

Exclusion criteria

• Pregnancy
• Malignancy
• NSAID hypersensitivity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Rofexocib 25 mg OD, 1 year treatment

Treatment:

Drug: Rofecoxib

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo