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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00390260 |
Study the effect of rofecoxib 50 mg compared to both placebo, and hydrocodone 7.5 mg with acetaminophen 750 mg, to treat moderate to severe pain following arthroscopic knee surgery.
Condition | Intervention | Phase |
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Pain, Postoperative Arthroscopy. |
Drug: MK0966 / Duration of Treatment: 1 Days Drug: Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days Drug: Comparator: placebo (unspecified) / Duration of Treatment: 1 Days |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Rofecoxib 50 mg and Hydrocodone 7.5 mg With Acetaminophen 750 mg in Patients With Postoperative Arthroscopic Pain |
Estimated Enrollment: | 420 |
Study Start Date: | February 2002 |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2006_535 |
Study First Received: | October 18, 2006 |
Last Updated: | October 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00390260 |
Health Authority: | United States: Food and Drug Administration |
Naphazoline Oxymetazoline Signs and Symptoms Postoperative Complications Guaifenesin Phenylephrine |
Hydrocodone Rofecoxib Pain Phenylpropanolamine Acetaminophen Pain, Postoperative |
Respiratory System Agents Physiological Effects of Drugs Central Nervous System Depressants Narcotics Pharmacologic Actions Pathologic Processes Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Antitussive Agents Central Nervous System Agents Analgesics, Opioid |