Coxib-inhibition of Duodenal Polyp Growth in FAP

NCT ID: NCT00844727

Last Updated: 2011-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2004-04-30

Brief Summary

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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

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Conditions

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Duodenal Polyposis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Rofexocib 25 mg OD, 1 year treatment

Group Type ACTIVE_COMPARATOR

Rofecoxib

Intervention Type DRUG

2

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo pills

Interventions

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Rofecoxib

Intervention Type DRUG

placebo

placebo pills

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* FAP patient with previous colectomy and confirmed polyposis

Exclusion Criteria

* Pregnancy
* Malignancy
* NSAID hypersensitivity
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Locations

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Dept of Medicine, Rikshospitalet

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

Other Identifiers

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RH01/01

Identifier Type: -

Identifier Source: org_study_id

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