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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00393354
Recruitment Status : Completed
First Posted : October 27, 2006
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Recurrent Low Back Pain Drug: MK0663, Etoricoxib / Duration of Treatment : 12 Weeks Drug: Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial to Assess the Efficacy and Safety of MK0663 in Patients With Chronic Low Back Pain
Study Start Date : April 2000
Primary Completion Date : November 2000
Study Completion Date : November 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393354


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00393354     History of Changes
Other Study ID Numbers: 0663-041
2006_548
First Posted: October 27, 2006    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents