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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00393354
First received: October 26, 2006
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

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

Estimated Enrollment: 300
Study Start Date: April 2000
Primary Completion Date: November 2000 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393354

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

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00393354     History of Changes
Other Study ID Numbers: 2006_548, MK0663-041
Study First Received: October 26, 2006
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014