Study of MK0663 in Patients With Chronic Low Back Pain (0663-806)(COMPLETED)
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| ClinicalTrials.gov Identifier: NCT00090181 |
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Recruitment Status :
Completed
First Posted : August 27, 2004
Last Update Posted : November 30, 2015
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Brief Summary:
The purpose of this study is to evaluate the efficacy of MK0663 for the treatment of chronic low back pain and to investigate the overall safety and tolerability over four weeks of treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Low Back Pain | Drug: MK0663, etoricoxib / Duration of Treatment: 4 weeks Drug: Comparator: diclofenac / Duration of Treatment: 4 weeks | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 401 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Double-Blind, Parallel-group, 4-Week Trial to Assess the Efficacy and Safety of Etoricoxib 60 mg and Diclofenac 150 mg in Patients With Chronic Low Back Pain |
| Study Start Date : | June 2004 |
| Actual Primary Completion Date : | March 2005 |
| Actual Study Completion Date : | March 2005 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Back Pain
Drug Information available for:
Diclofenac
Primary Outcome Measures :
- Lower back pain intensity
- Safety and tolerability
Secondary Outcome Measures :
- Disability questionnaire
- Patient global assessment of response to therapy
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female patients 18 years of age or older, who have Chronic Low Back Pain after the discontinuation of their previous medication for their condition.
- Patients should have at least 3 months of Low Back Pain.
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): NCT00090181
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Publications:
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00090181 History of Changes |
| Other Study ID Numbers: |
0663-806 2004_003 |
| First Posted: | August 27, 2004 Key Record Dates |
| Last Update Posted: | November 30, 2015 |
| Last Verified: | November 2015 |
Keywords provided by Merck Sharp & Dohme Corp.:
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Arcoxia |
Additional relevant MeSH terms:
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Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Diclofenac Etoricoxib 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 Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cyclooxygenase 2 Inhibitors |