Osteoarthritis of the KneePhase 3NCT00568295
A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee
A Phase 3 study testing acetaminophen and Rofecoxib in people with Osteoarthritis of the Knee, run by Johnson & Johnson Consumer and Personal Products Worldwide.
Trial summary
To compare acetaminophen (Tylenol) with rofecoxib (Viox) for the treatment of Osteoarthritis of the Knee Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- acetaminophen and Rofecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 403 participants
- Where
- No sites listed yet
- Study dates
- Oct 1999to Oct 2000
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
To compare acetaminophen (Tylenol) with rofecoxib (Viox) for the treatment of Osteoarthritis of the Knee
Read the 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.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- acetaminophen, Rofecoxib
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophenDrug
Also called Tylenol
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.
RofecoxibDrug
Also called Viox
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.
RofecoxibDrug
Also called Viox
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.
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen | Experimental | Acetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP Receives: Drug: acetaminophen |
| Refecoxib 12.5 mg | Active comparator | Rofecoxib: Capsules 12.5 mg, oral, C-904-1A Receives: Drug: Rofecoxib |
| Rofecoxib 12.5 x 2 | Active comparator | Rofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A Receives: Drug: Rofecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Western Ontario and McMaster Universities (WOMAC) pain subscale score at week 4 in the per protocol study population.
Measured: Four Weeks
Secondary outcomes (7)
Change from Baseline in the WOMAC pain subscale score
Measured: Weeks 1 and 2
Change from baseline in the WOMAC stiffness and physical function subscale scores
Measured: Weeks 1, 2 and 4
Investigator's impression of therapeutic response
Measured: Weeks 1, 2, and 4
Subject's assessment of medication as an analgesic for the study knee joint
Measured: Weeks 1, 2, and 4
Daily pain intensity differences from baseline
Measured: Week 1
Investigator's global impression of therapeutic response
Measured: Week 4
Subject's overall impression of the study medication
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startOct 1999
- Primary completionOct 2000
- Study completionOct 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edwin Kuffner, MD, Study director, McNeil Consumer Healthcare USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568295
- Sponsor's protocol ID
- 99-090
- Status last verified
- Aug 2011
- First submitted
- 4 Dec 2007
- Last updated
- 22 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00568295
- Acronym / sponsor ID
- 99-090
- Conditions
- Osteoarthritis of the Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Oct 1999
- Primary completion
- Oct 2000 (actual)
- Study completion
- Oct 2000 (actual)
- First posted
- 6 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen | Experimental | Drug: acetaminophenAcetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP |
| Refecoxib 12.5 mg | Active comparator | Drug: RofecoxibRofecoxib: Capsules 12.5 mg, oral, C-904-1A |
| Rofecoxib 12.5 x 2 | Active comparator | Drug: RofecoxibRofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetaminophenAlso: TylenolAcetaminophen 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. | Drug | Acetaminophen |
| RofecoxibAlso: VioxRofecoxib: 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. | Drug | Refecoxib 12.5 mg |
| RofecoxibAlso: VioxRofecoxib: 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. | Drug | Rofecoxib 12.5 x 2 |
Primary outcome
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
7 secondary outcomes
Change from Baseline in the WOMAC pain subscale score
Time frame: Weeks 1 and 2
Change from baseline in the WOMAC stiffness and physical function subscale scores
Time frame: Weeks 1, 2 and 4
Investigator's impression of therapeutic response
Time frame: Weeks 1, 2, and 4
Subject's assessment of medication as an analgesic for the study knee joint
Time frame: Weeks 1, 2, and 4
Daily pain intensity differences from baseline
Time frame: Week 1
Investigator's global impression of therapeutic response
Time frame: Week 4
Subject's overall impression of the study medication
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin Kuffner, MD study director
McNeil Consumer Healthcare USA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acetaminophen and Rofecoxib in people with Osteoarthritis of the Knee, run by Johnson & Johnson Consumer and Personal Products Worldwide.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2011.