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

Primary Purpose

Pain, Postoperative Arthroscopy

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0966 / Duration of Treatment: 1 Days
Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days
Comparator: placebo (unspecified) / Duration of Treatment: 1 Days
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative Arthroscopy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 18, 2006
    Last Updated
    January 31, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00390260
    Brief Title
    Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2002 (undefined)
    Primary Completion Date
    February 2003 (Actual)
    Study Completion Date
    February 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative Arthroscopy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    420 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0966 / Duration of Treatment: 1 Days
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo (unspecified) / Duration of Treatment: 1 Days
    Primary Outcome Measure Information:
    Title
    Total Pain Relief over 6 hours following a single oral dose compared to placebo.
    Time Frame
    6 hours
    Secondary Outcome Measure Information:
    Title
    Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen.
    Time Frame
    6 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17207303
    Citation
    Chelly JE, Nissen CW, Rodgers AJ, Smugar SS, Tershakovec AM. The efficacy of rofecoxib 50 mg and hydrocodone/acetaminophen 7.5/750 mg in patients with post-arthroscopic pain. Curr Med Res Opin. 2007 Jan;23(1):195-206. doi: 10.1185/030079907X162647.
    Results Reference
    background
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

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

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