Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: October 18, 2006
Last updated: July 3, 2015
Last verified: July 2015
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
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Total Pain Relief over 6 hours following a single oral dose compared to placebo. [ Time Frame: 6 hours ]

Secondary Outcome Measures:
  • Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen. [ Time Frame: 6 hours ]

Estimated Enrollment: 420
Study Start Date: February 2002
Study Completion Date: February 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Elective outpatient arthroscopic knee surgery expected to last <= 90 minutes using general anesthesia
  • Patients must experience moderate to severe pain following surgery
  • Patient must be in general good health as judged by the primary investigator

Exclusion Criteria:

  • Osteoarthritis; rheumatoid arthritis
  • Allergy/sensitivity to aspirin, ibuprofen, indomethacin, other NSAIDs, COX-2 inhibitors (e.g., rofecoxib, celecoxib), hydrocodone, acetaminophen
  • Asthma associated with nasal polyps
  • Any arthroscopic knee surgery in the past 6 months
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00390260

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00390260     History of Changes
Other Study ID Numbers: 0966-179  2006_535 
Study First Received: October 18, 2006
Last Updated: July 3, 2015

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on January 19, 2017