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CompletedNCT00092742Updated Feb 16, 2022

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

A Phase 3 interventional study of MK0663, etoricoxib and Comparator: Diclofenac sodium in Rheumatoid Arthritis, sponsored by Organon and Co. Completed. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-02-16.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
4,086
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the detailed description

The duration of treatment is 12 months.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Arcoxia
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 4,086 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Males and females 50 years or older with rheumatoid arthritis.

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
4,086 participants (actual)

Interventions

  • DrugMK0663, etoricoxib
  • DrugComparator: Diclofenac sodium
06

What researchers measure

Primary outcomes

  1. Discontinuations due to clinical and laboratory gastrointestinal adverse experiences

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Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 17113426 ↗
  • 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. PubMed 17965424 ↗
  • 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. PubMed 19380329 ↗
  • 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. PubMed 18823986 ↗
  • 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. PubMed 19174782 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00092742
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Sep 28, 2004
Start date
Feb 2003
Primary completion
Dec 2005
Completion
Dec 2005
Last update
Feb 16, 2022

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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