CClinicalTrials.gg
CompletedNCT00092703Updated Aug 15, 2024

Investigational Drug Versus an Approved Drug in Patients With Osteoarthritis (0663-061)(COMPLETED)

A Phase 3 interventional study of MK0663, etoricoxib and Comparator: Diclofenac sodium in Osteoarthritis, sponsored by Organon and Co. Completed. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.

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

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Jun 2002, registered Sep 2004).
Phase
Phase 3
Study type
Interventional
Enrollment
6,000
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the gastrointestinal tolerability of an investigational drug to an approved drug in the treatment of osteoarthritis during one year treatment period.

Read the detailed description

The duration of treatment is 12 months.

02

Conditions studied

  • Osteoarthritis

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Keywords

  • Arcoxia
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 6,000 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis 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

  • Osteoarthritis of the knee, hip, hand or spine which requires the use of medications for pain relief

Exclusion criteria

Exclusion Criteria:

  • Known allergies to the study drugs
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
6,000 participants

Interventions

  • DrugMK0663, etoricoxib
  • DrugComparator: Diclofenac sodium
06

What researchers measure

Primary outcomes

  1. Discontinuations due to clinical and laboratory gastrointestinal adverse experiences during a 1 year treatment period.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Baraf HS, Fuentealba C, Greenwald M, Brzezicki J, O'Brien K, Soffer B, Polis A, Bird S, Kaur A, Curtis SP; EDGE Study Group. Gastrointestinal side effects of etoricoxib in patients with osteoarthritis: results of the Etoricoxib versus Diclofenac Sodium Gastrointestinal Tolerability and Effectiveness (EDGE) trial. J Rheumatol. 2007 Feb;34(2):408-20. PubMed 17304660 ↗
  • 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 ↗
  • 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. PubMed 17292766 ↗
  • 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 Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00092703
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Sep 28, 2004
Start date
Jun 27, 2002
Primary completion
Nov 1, 2003
Completion
Nov 1, 2003
Last update
Aug 15, 2024

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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