search
Back to results

A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
acetaminophen
Rofecoxib
Rofecoxib
Sponsored by
Johnson & Johnson Consumer and Personal Products Worldwide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptomatic idiopathic osteoarthritis of the knee for a minimum of six months duration requiring treatment with either an analgesic or anti-inflammatory agent on a regular basis (greater than or equal to three days/week) for at least three months.
  • A history of osteoarthritis of the knee characterized by pain of at least a moderate intensity.
  • Demonstrated radiographic evidence of mild to moderate osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria of grade 2 or 3 osteoarthritis.
  • Subjects' physical ability was to be either American College of Rheumatology (ACR) Function Class I or II
  • At the baseline visit, subjects must have reported a maximum pain intensity experienced over the previous 24 hours of at least moderate on a five-point scale of none(0), mild(1), moderate(2), moderately severe(3), or severe(4) in order to be enrolled in the study.

Exclusion Criteria:

  • Medical history, physical examinations, or radiographs suggestive of other types of arthritis, pseudogout, collagen vascular disease or fibromyalgia.
  • Medical or psychiatric conditions that may influence absorption, metabolism, or excretion of the study medications or interfere with interpretation of adverse reactions to the study drug.
  • History of allergy, sensitivity, contraindication or non-response to acetaminophen, rofecoxib, or drugs classified as NSAIDs including aspirin.
  • Use of concomitant medications that might interfere with study drug assessments, including intra-articular corticosteroids.
  • Signs of active knee inflammation, morning stiffness of greater than 30 minutes duration.
  • Rheumatoid factor quantitative value greater than or equal to 40 IU/mL or a Westergren erythrocyte sedimentation rate greater than or equal to 40 mm/hour.
  • ACR functional class III or IV, or unable to walk without assistive devices.
  • Pregnancy, lactation, or expect to become pregnant within one month of study completion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Acetaminophen

    Refecoxib 12.5 mg

    Rofecoxib 12.5 x 2

    Arm Description

    Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP

    Rofecoxib: Capsules 12.5 mg, oral, C-904-1A

    Rofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A

    Outcomes

    Primary Outcome Measures

    Change from Baseline in the Western Ontario and McMaster Universities (WOMAC) pain subscale score at week 4 in the per protocol study population.

    Secondary Outcome Measures

    Change from Baseline in the WOMAC pain subscale score
    Change from baseline in the WOMAC stiffness and physical function subscale scores
    Investigator's impression of therapeutic response
    Subject's assessment of medication as an analgesic for the study knee joint
    Daily pain intensity differences from baseline
    Investigator's global impression of therapeutic response
    Subject's overall impression of the study medication

    Full Information

    First Posted
    December 4, 2007
    Last Updated
    August 19, 2011
    Sponsor
    Johnson & Johnson Consumer and Personal Products Worldwide
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00568295
    Brief Title
    A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee
    Official Title
    A Four-Week Comparative Study Evaluating Acetaminophen Extended Release (3900 mg/Day) and Rofecoxib (12.5 mg/Day and 25 mg/Day)in the Treatment of Osteoarthritis of the Knee
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1999 (undefined)
    Primary Completion Date
    October 2000 (Actual)
    Study Completion Date
    October 2000 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johnson & Johnson Consumer and Personal Products Worldwide

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To compare acetaminophen (Tylenol) with rofecoxib (Viox) for the treatment of Osteoarthritis of the Knee
    Detailed Description
    An initial screening visit was performed in order to assess subject medical history and the potential eligibility of subjects. Following the initial screening visit, all potential subjects underwent a washout period from their usual arthritis medication and returned to the study center for a baseline visit to verify their eligibility. At the completion of the baseline visit, all eligible subjects were randomly assigned to a treatment group and instructed on the dosing regimen for their assigned study medication. Subjects returned to the study center for follow-up visits after Week 1 and Week 2 of treatment and a final visit after Week 4 of treatment or upon discontinuation from the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis of the Knee

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    403 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acetaminophen
    Arm Type
    Experimental
    Arm Description
    Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP
    Arm Title
    Refecoxib 12.5 mg
    Arm Type
    Active Comparator
    Arm Description
    Rofecoxib: Capsules 12.5 mg, oral, C-904-1A
    Arm Title
    Rofecoxib 12.5 x 2
    Arm Type
    Active Comparator
    Arm Description
    Rofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A
    Intervention Type
    Drug
    Intervention Name(s)
    acetaminophen
    Other Intervention Name(s)
    Tylenol
    Intervention Description
    Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.
    Intervention Type
    Drug
    Intervention Name(s)
    Rofecoxib
    Other Intervention Name(s)
    Viox
    Intervention Description
    Rofecoxib: Capsules 12.5 mg, oral, C-904-1A - - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.
    Intervention Type
    Drug
    Intervention Name(s)
    Rofecoxib
    Other Intervention Name(s)
    Viox
    Intervention Description
    Rofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.
    Primary Outcome Measure Information:
    Title
    Change from Baseline in the Western Ontario and McMaster Universities (WOMAC) pain subscale score at week 4 in the per protocol study population.
    Time Frame
    Four Weeks
    Secondary Outcome Measure Information:
    Title
    Change from Baseline in the WOMAC pain subscale score
    Time Frame
    Weeks 1 and 2
    Title
    Change from baseline in the WOMAC stiffness and physical function subscale scores
    Time Frame
    Weeks 1, 2 and 4
    Title
    Investigator's impression of therapeutic response
    Time Frame
    Weeks 1, 2, and 4
    Title
    Subject's assessment of medication as an analgesic for the study knee joint
    Time Frame
    Weeks 1, 2, and 4
    Title
    Daily pain intensity differences from baseline
    Time Frame
    Week 1
    Title
    Investigator's global impression of therapeutic response
    Time Frame
    Week 4
    Title
    Subject's overall impression of the study medication
    Time Frame
    Week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Symptomatic idiopathic osteoarthritis of the knee for a minimum of six months duration requiring treatment with either an analgesic or anti-inflammatory agent on a regular basis (greater than or equal to three days/week) for at least three months. A history of osteoarthritis of the knee characterized by pain of at least a moderate intensity. Demonstrated radiographic evidence of mild to moderate osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria of grade 2 or 3 osteoarthritis. Subjects' physical ability was to be either American College of Rheumatology (ACR) Function Class I or II At the baseline visit, subjects must have reported a maximum pain intensity experienced over the previous 24 hours of at least moderate on a five-point scale of none(0), mild(1), moderate(2), moderately severe(3), or severe(4) in order to be enrolled in the study. Exclusion Criteria: Medical history, physical examinations, or radiographs suggestive of other types of arthritis, pseudogout, collagen vascular disease or fibromyalgia. Medical or psychiatric conditions that may influence absorption, metabolism, or excretion of the study medications or interfere with interpretation of adverse reactions to the study drug. History of allergy, sensitivity, contraindication or non-response to acetaminophen, rofecoxib, or drugs classified as NSAIDs including aspirin. Use of concomitant medications that might interfere with study drug assessments, including intra-articular corticosteroids. Signs of active knee inflammation, morning stiffness of greater than 30 minutes duration. Rheumatoid factor quantitative value greater than or equal to 40 IU/mL or a Westergren erythrocyte sedimentation rate greater than or equal to 40 mm/hour. ACR functional class III or IV, or unable to walk without assistive devices. Pregnancy, lactation, or expect to become pregnant within one month of study completion.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edwin Kuffner, MD
    Organizational Affiliation
    McNeil Consumer Healthcare USA
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee

    We'll reach out to this number within 24 hrs