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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00568295
First received: December 4, 2007
Last updated: August 19, 2011
Last verified: August 2011

December 4, 2007
August 19, 2011
October 1999
October 2000   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00568295 on ClinicalTrials.gov Archive Site
  • Change from Baseline in the WOMAC pain subscale score [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]
  • Change from baseline in the WOMAC stiffness and physical function subscale scores [ Time Frame: Weeks 1, 2 and 4 ] [ Designated as safety issue: No ]
  • Investigator's impression of therapeutic response [ Time Frame: Weeks 1, 2, and 4 ] [ Designated as safety issue: No ]
  • Subject's assessment of medication as an analgesic for the study knee joint [ Time Frame: Weeks 1, 2, and 4 ] [ Designated as safety issue: No ]
  • Daily pain intensity differences from baseline [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
  • Investigator's global impression of therapeutic response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Subject's overall impression of the study medication [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee
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

To compare acetaminophen (Tylenol) with rofecoxib (Viox) for the treatment of Osteoarthritis of the Knee

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoarthritis of the Knee
  • Drug: acetaminophen
    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.
    Other Name: Tylenol
  • Drug: Rofecoxib
    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.
    Other Name: Viox
  • Drug: Rofecoxib
    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.
    Other Name: Viox
  • Experimental: Acetaminophen
    Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP
    Intervention: Drug: acetaminophen
  • Active Comparator: Refecoxib 12.5 mg
    Rofecoxib: Capsules 12.5 mg, oral, C-904-1A
    Intervention: Drug: Rofecoxib
  • Active Comparator: Rofecoxib 12.5 x 2
    Rofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A
    Intervention: Drug: Rofecoxib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
403
October 2000
October 2000   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00568295
99-090
No
Johnson & Johnson Consumer and Personal Products Worldwide
Johnson & Johnson Consumer and Personal Products Worldwide
Not Provided
Study Director: Edwin Kuffner, MD McNeil Consumer Healthcare USA
Johnson & Johnson Consumer and Personal Products Worldwide
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP