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OpenTrials
Completed

NCT Number: NCT00390260

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

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.

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Key information

Conditions

Pain, Postoperative Arthroscopy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

  1. Total Pain Relief over 6 hours following a single oral dose compared to placebo.

    Time frame: 6 hours

Secondary outcomes

  1. Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen.

    Time frame: 6 hours

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Oct 19, 2006
Registry last updated
Feb 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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