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CompletedNCT00393354Updated Feb 18, 2022

Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-041)

A Phase 3 interventional study of MK0663, Etoricoxib / Duration of Treatment : 12 Weeks and Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks in Recurrent Low Back Pain, sponsored by Organon and Co. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-02-18.

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

Phase
Phase 3
Study type
Interventional
Enrollment
325
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back pain.

02

Conditions studied

  • Recurrent Low Back Pain

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03

In context

Low Back Pain

2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.

This study's enrollment of 325 is above the median of 60 across 2,315 interventional studies indexed under Low Back Pain.

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Lead sponsor

Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Low back pain for previous 3 months and majority of days in last month
  • Regular use of acetaminophen or NSAID to treat low back pain in past month
  • Judged to be in otherwise good health

Exclusion criteria

Exclusion Criteria:

  • Low back pain that is due to secondary causes
  • Radicular/myelopathic pain
  • Surgery for low back pain within the past 6 months
  • Active lawsuit or claim pertaining to their low back pain
  • Disease that may confound the results of the study or pose risk to the patients
  • Corticosteroid use in past month
  • Previous participation in MK0663 study
05

Study design

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

Interventions

  • DrugMK0663, Etoricoxib / Duration of Treatment : 12 Weeks
  • DrugComparator : placebo (unspecified) /Duration of Treatment : 12 Weeks
06

What researchers measure

Primary outcomes

  1. Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo

Secondary outcomes

  1. Low back pain intensity scale (0-100 mm VAS) over 12 weeks compared to placebo

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Pallay RM, Seger W, Adler JL, Ettlinger RE, Quaidoo EA, Lipetz R, O'Brien K, Mucciola L, Skalky CS, Petruschke RA, Bohidar NR, Geba GP. Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial. Scand J Rheumatol. 2004;33(4):257-66. doi: 10.1080/03009740410005728. PubMed 15370723 ↗
  • Curtis SP, Ng J, Yu Q, Shingo S, Bergman G, McCormick CL, Reicin AS. Renal effects of etoricoxib and comparator nonsteroidal anti-inflammatory drugs in controlled clinical trials. Clin Ther. 2004 Jan;26(1):70-83. doi: 10.1016/s0149-2918(04)90007-0. PubMed 14996519 ↗
  • Sheldon EA, Bird SR, Smugar SS, Tershakovec AM. Correlation of measures of pain, function, and overall response: results pooled from two identical studies of etoricoxib in chronic low back pain. Spine (Phila Pa 1976). 2008 Mar 1;33(5):533-8. doi: 10.1097/BRS.0b013e3181657d24. PubMed 18317199 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00393354
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Oct 27, 2006
Start date
Apr 2000
Primary completion
Nov 2000
Completion
Nov 2000
Last update
Feb 18, 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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