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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00404183 |
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended Release Hydrocodone/Acetaminophen with placebo over a 5-week dosing period in patients with osteoarthritis.
Condition | Intervention | Phase |
---|---|---|
Pain |
Drug: Extended-Release Hydrocodone/Acetaminophen (Vicodin® CR) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Multi-Center, Double-Blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis |
Estimated Enrollment: | 120 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | March 2005 |
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | M03-643 |
Study First Received: | November 26, 2006 |
Last Updated: | July 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00404183 |
Health Authority: | United States: Food and Drug Administration |
Pain associated with osteoarthritis |
Osteoarthritis Joint Diseases Pain Rheumatic Diseases Naphazoline Oxymetazoline Musculoskeletal Diseases |
Phenylephrine Guaifenesin Arthritis Hydrocodone Phenylpropanolamine Acetaminophen |
Respiratory System Agents Physiological Effects of Drugs Central Nervous System Depressants Narcotics Pharmacologic Actions Analgesics, Non-Narcotic Sensory System Agents |
Therapeutic Uses Analgesics Peripheral Nervous System Agents Antitussive Agents Central Nervous System Agents Analgesics, Opioid |