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Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0663, etoricoxib
Comparator: Diclofenac sodium
Sponsored by
Organon and Co
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Arcoxia

Eligibility Criteria

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

Inclusion Criteria: Males and females 50 years or older with rheumatoid arthritis. Exclusion Criteria: History of gastrointestinal malabsorption or inflammatory bowel disease History of heart problems such as: congestive heart failure (CHF), heart attack or high blood pressure.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Discontinuations due to clinical and laboratory gastrointestinal adverse experiences

    Secondary Outcome Measures

    Full Information

    First Posted
    September 23, 2004
    Last Updated
    February 4, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00092742
    Brief Title
    Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072)
    Official Title
    A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of Etoricoxib 90 mg q.d. vs. Diclofenac Sodium 75 mg b.i.d. in Patients With Rheumatoid Arthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2003 (undefined)
    Primary Completion Date
    December 2005 (Actual)
    Study Completion Date
    December 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the long-term safety of an investigational drug versus an approved drug for the relief of pain in patients with rheumatoid arthritis.
    Detailed Description
    The duration of treatment is 12 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    Arcoxia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    4086 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0663, etoricoxib
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Diclofenac sodium
    Primary Outcome Measure Information:
    Title
    Discontinuations due to clinical and laboratory gastrointestinal adverse experiences

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males and females 50 years or older with rheumatoid arthritis. Exclusion Criteria: History of gastrointestinal malabsorption or inflammatory bowel disease History of heart problems such as: congestive heart failure (CHF), heart attack or high blood pressure.
    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

    Citations:
    PubMed Identifier
    17113426
    Citation
    Cannon CP, Curtis SP, FitzGerald GA, Krum H, Kaur A, Bolognese JA, Reicin AS, Bombardier C, Weinblatt ME, van der Heijde D, Erdmann E, Laine L; MEDAL Steering Committee. Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. Lancet. 2006 Nov 18;368(9549):1771-81. doi: 10.1016/S0140-6736(06)69666-9.
    Results Reference
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    PubMed Identifier
    17965424
    Citation
    Krueger K, Lino L, Dore R, Radominski S, Zhang Y, Kaur A, Simpson R, Curtis S. Gastrointestinal tolerability of etoricoxib in rheumatoid arthritis patients: results of the etoricoxib vs diclofenac sodium gastrointestinal tolerability and effectiveness trial (EDGE-II). Ann Rheum Dis. 2008 Mar;67(3):315-22. doi: 10.1136/ard.2007.082388. Epub 2007 Oct 27. Erratum In: Ann Rheum Dis.2008 May;67(5):732.
    Results Reference
    background
    PubMed Identifier
    19380329
    Citation
    Krum H, Curtis SP, Kaur A, Wang H, Smugar SS, Weir MR, Laine L, Brater DC, Cannon CP. Baseline factors associated with congestive heart failure in patients receiving etoricoxib or diclofenac: multivariate analysis of the MEDAL program. Eur J Heart Fail. 2009 Jun;11(6):542-50. doi: 10.1093/eurjhf/hfp054. Epub 2009 Apr 19.
    Results Reference
    background
    PubMed Identifier
    18823986
    Citation
    Laine L, Curtis SP, Langman M, Jensen DM, Cryer B, Kaur A, Cannon CP. Lower gastrointestinal events in a double-blind trial of the cyclo-oxygenase-2 selective inhibitor etoricoxib and the traditional nonsteroidal anti-inflammatory drug diclofenac. Gastroenterology. 2008 Nov;135(5):1517-25. doi: 10.1053/j.gastro.2008.07.067. Epub 2008 Aug 3.
    Results Reference
    background
    PubMed Identifier
    19174782
    Citation
    Laine L, Goldkind L, Curtis SP, Connors LG, Yanqiong Z, Cannon CP. How common is diclofenac-associated liver injury? Analysis of 17,289 arthritis patients in a long-term prospective clinical trial. Am J Gastroenterol. 2009 Feb;104(2):356-62. doi: 10.1038/ajg.2008.149. Epub 2009 Jan 27.
    Results Reference
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    Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072)

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