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
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Arcoxia
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Discontinuations due to clinical and laboratory gastrointestinal adverse experiences
Secondary Outcome Measures
Full Information
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
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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
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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
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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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