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

NCT ID: NCT00393354

Last Updated: 2022-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2000-11-30

Brief Summary

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

Detailed Description

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Conditions

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Recurrent Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0663, Etoricoxib / Duration of Treatment : 12 Weeks

Intervention Type DRUG

Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type BACKGROUND
PMID: 15370723 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14996519 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18317199 (View on PubMed)

Other Identifiers

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2006_548

Identifier Type: -

Identifier Source: secondary_id

0663-041

Identifier Type: -

Identifier Source: org_study_id

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