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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00195728 |
The purpose of the study is to evaluate the safety of Vicodin CR (combination opioid and acetaminophen containing product) in patients with chronic pain due to osteoarthritis or low back pain.
Condition | Intervention | Phase |
---|---|---|
Moderate to Severe Chronic, Non-Malignant Pain |
Drug: Hydrocodone/Acetaminophen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | An Open-Label Study Evaluating the Safety and Tolerability of Long Term Administration of Hydrocodone/Acetaminophen Extended ReleaseTablets (Vicodin® CR) in Subjects With Moderate to Severe Chronic, Non-Malignant Pain |
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Males and Females between 21 and 75 years of age
Exclusion Criteria:
History of any of the following:
Has received
Study ID Numbers: | M03-666 |
Study First Received: | September 13, 2005 |
Last Updated: | October 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00195728 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hydrocodone/Acetaminophen Vicodin CR |
Oxycodone Central Nervous System Depressants Pain Narcotics Naphazoline Analgesics, Non-Narcotic Guaifenesin |
Hydrocodone Analgesics Peripheral Nervous System Agents Phenylpropanolamine Acetaminophen Analgesics, Opioid |
Respiratory System Agents Oxycodone Physiological Effects of Drugs Central Nervous System Depressants Narcotics Pharmacologic Actions Analgesics, Non-Narcotic Sensory System Agents |
Therapeutic Uses Hydrocodone Analgesics Peripheral Nervous System Agents Antitussive Agents Central Nervous System Agents Acetaminophen Analgesics, Opioid |