A Study to Evaluate the Safety of an Investigational Drug (Etoricoxib) in Patients With Osteoarthritis (OA) or Rheumatoid Arthritis (RA)(0663-066)

NCT00250445 | Completed Phase 3

• 2 other identifiers: 0663-0662005_100
• Study Type: interventional
• Target: 23,498
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is designed to compare the risk of cardiovascular events (heart attacks, strokes) in patients receiving either etoricoxib or diclofenac. It will also compare the gastrointestinal tolerability of the two medicines. The study will be conducted in patients with either rheumatoid or osteo-arthritis.

Conditions

Rheumatoid Arthritis,Osteoarthritis

Keywords

Arcoxia

Outcome Measures

Primary Outcomes (1)

• Incidence of Confirmed Thrombotic Cardiovascular Serious Adverse Experiences based on combined data from this trial and MK0663 Protocols 061 & 072 (GI Tolerability in OA Patients and GI Tolerability Study in RA Patients ), respectively.

Secondary Outcomes (1)

• Incidence of Confirmed Thrombotic Cardiovascular Serious Adverse Experiences from this trial alone. Gastrointestinal tolerability based on the percentage of patients that discontinue for clinical or laboratory gastrointestinal adverse experiences.

Interventions

MK0663, etoricoxib DRUG

Comparator: Diclofenac sodium DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has a clinical diagnosis of either Osteoarthritis or Rheumatoid Arthritis and in the opinion of the investigator will require chronic nonsteroidal anti-inflammatory or COX-2 inhibitor therapy for at least 1.5 years

You may not qualify if:

• Concurrent medical or arthritic disease that could confound or interfere with efficacy evaluation.
• Concomitant therapy of warfarin, heparin, high-dose aspirin (\>100 mg/day).
• Impaired kidney function, clinical gastrointestinal malabsorption, congestive heart failure with symptoms that occur at rest, unstable angina, uncontrolled high blood pressure, active hepatitis/hepatic disease

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (7)

• 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.

  PMID: 17113426 BACKGROUND

• Laine L, Curtis SP, Cryer B, Kaur A, Cannon CP; MEDAL Steering Committee. Assessment of upper gastrointestinal safety of 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. 2007 Feb 10;369(9560):465-73. doi: 10.1016/S0140-6736(07)60234-7.

  PMID: 17292766 BACKGROUND

• 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.

  PMID: 19380329 BACKGROUND

• 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.

  PMID: 18823986 BACKGROUND

• 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.

  PMID: 19174782 BACKGROUND

• Combe B, Swergold G, McLay J, McCarthy T, Zerbini C, Emery P, Connors L, Kaur A, Curtis S, Laine L, Cannon CP. Cardiovascular safety and gastrointestinal tolerability of etoricoxib vs diclofenac in a randomized controlled clinical trial (The MEDAL study). Rheumatology (Oxford). 2009 Apr;48(4):425-32. doi: 10.1093/rheumatology/kep005. Epub 2009 Feb 17.

  PMID: 19223284 BACKGROUND

• Krum H, Swergold G, Curtis SP, Kaur A, Wang H, Smugar SS, Weir MR, Laine L, Brater DC, Cannon CP. Factors associated with blood pressure changes in patients receiving diclofenac or etoricoxib: results from the MEDAL study. J Hypertens. 2009 Apr;27(4):886-93. doi: 10.1097/HJH.0b013e328325d831.

  PMID: 19516186 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2005
• First Posted: November 8, 2005
• Study Start: January 1, 2003
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: February 18, 2022

Record last verified: 2022-02