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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00393354
First received: October 26, 2006
Last updated: July 15, 2014
Last verified: July 2014
  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

Enrollment: 325
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00393354     History of Changes
Other Study ID Numbers: 0663-041, 2006_548
Study First Received: October 26, 2006
Last Updated: July 15, 2014
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 July 24, 2014