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

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ClinicalTrials.gov Identifier: NCT00390260
Recruitment Status : Completed
First Posted : October 19, 2006
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : February 2002
Actual Primary Completion Date : February 2003
Actual Study Completion Date : February 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

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


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

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

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): NCT00390260


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

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00390260     History of Changes
Other Study ID Numbers: 0966-179
2006_535
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Acetaminophen
Rofecoxib
Hydrocodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
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