A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP) (0966-205)(TERMINATED)

NCT ID: NCT00140894

Last Updated: 2019-09-20

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

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-06

Study Completion Date

2004-10-11

Brief Summary

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A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis.

Detailed Description

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Conditions

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Adenomatous Polyposis Coli

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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MK0966; rofecoxib / Duration of Treatment: 24 weeks

Intervention Type DRUG

Comparator: placebo / Duration of Treatment: 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or females at least 18 years of age with familial adenomatous polyposis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2005_052

Identifier Type: -

Identifier Source: secondary_id

0966-205

Identifier Type: -

Identifier Source: org_study_id

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