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

Primary Purpose

Adenomatous Polyposis Coli

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK0966; rofecoxib / Duration of Treatment: 24 weeks
Comparator: placebo / Duration of Treatment: 24 weeks
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenomatous Polyposis Coli focused on measuring Osteoarthritis, Cancer Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males or females at least 18 years of age with familial adenomatous polyposis.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Number and average size of rectal polyps
    Safety and tolerability

    Secondary Outcome Measures

    Number and average size of duodenal polyps
    Proportions of patients with improved overall colon rating

    Full Information

    First Posted
    August 30, 2005
    Last Updated
    September 18, 2019
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00140894
    Brief Title
    A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP) (0966-205)(TERMINATED)
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Rofecoxib in Familial Adenomatous Polyposis (FAP)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Terminated
    Study Start Date
    August 6, 2002 (Actual)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 11, 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adenomatous Polyposis Coli
    Keywords
    Osteoarthritis, Cancer Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    62 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0966; rofecoxib / Duration of Treatment: 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo / Duration of Treatment: 24 weeks
    Primary Outcome Measure Information:
    Title
    Number and average size of rectal polyps
    Title
    Safety and tolerability
    Secondary Outcome Measure Information:
    Title
    Number and average size of duodenal polyps
    Title
    Proportions of patients with improved overall colon rating

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males or females at least 18 years of age with familial adenomatous polyposis.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php

    Learn more about this trial

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

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