OsteoarthritisPhase 3NCT00240786
An Effectiveness and Safety Study of Two Doses of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee
A Phase 3 study testing acetaminophen extended release in people with Osteoarthritis, run by Johnson & Johnson Consumer and Personal Products Worldwide.
Trial summary
The purpose of this study is to determine the safety and effectiveness of 650 mg and 1300 mg acetaminophen extended release given three times a day for the relief of signs and symptoms of osteoarthritis of the hip or knee for a period of 12 weeks. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- acetaminophen extended release
- How many people
- 483 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Mar 2003
- 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
- Symptomats of osteoarthritis of the hip or knee for a minimum of six months
- History of hip or knee pain due to osteoarthritis requiring the use of NSAIDs, acetaminophen, or another analgesic agent on a regular basis (>= three days per week) for at least three months before the screening visit
- History of positive therapeutic benefit with acetaminophen use for osteoarthritis pain
- History of osteoarthritis pain (moderate, moderately severe, or severe) of the hip or knee when not taking osteoarthritis analgesic medication
- Must have a pain level of moderate or moderately severe for 24 hours over the previous 24 hours prior to the baseline visit, and at baseline, demonstrate a 20% or greater increase in the pain subscale score, relative to the score at screening
Who cannot join
- History of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit
- Grade 1 or grade 4 severity of the study joint based on the Kellgren and Lawrence radiographic criteria
- Maximum osteoarthritis pain intensity of none, mild or severe experienced over the previous 24 hours of the baseline visit
- Signs of clinically important active inflammation of the study knee joint including redness, warmth and/or a large, bulging effusion with the loss of normal contour at the screening and/or baseline visits
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Acetaminophen Extended Release (1950 mg/Day or 3900 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee
The purpose of this study is to determine the safety and effectiveness of 650 mg and 1300 mg acetaminophen extended release given three times a day for the relief of signs and symptoms of osteoarthritis of the hip or knee for a period of 12 weeks.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study to determine the safety and effectiveness of 650 mg and 1300 mg acetaminophen extended release given three times a day as compared with placebo, for the relief of signs and symptoms of osteoarthritis of the hip or knee for a period of 12 weeks. Propoxyphene Hydrochloride capsules 65 mg are used as rescue medication if subjects experience inadequate pain relief. The primary efficacy assessments are the average change from baseline to the final on-therapy visit for the WOMAN pain subscale score and the WOMAC physical function subscale scare, and the subject's average global assessment of their response to therapy through the final on-therapy visit. Safety assessments at study visits consist of monitoring adverse events, vital signs, study joint assessments and clinical laboratory determinations. The hypothesis is that 1950 mg per day and/or 3900 mg per day acetaminophen extended release are superior to placebo for the relief of the signs and symptoms of osteoarthritis of the hip or knee with respect to all three primary efficacy endpoints. Treatment consisted of either one 650 mg acetaminophen extended release caplet plus one placebo caplet (acetaminophen 1950 mg group); two 650 mg acetaminophen extended release caplets (acetaminophen 3900 mg group); or two placebo caplets administered orally every eight hours for 12 weeks.
- Conditions
- Osteoarthritis
- Being tested
- acetaminophen extended release
- Keywords
- osteoarthritis hip, osteoarthritis knee, acetaminophen
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophen extended releaseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change from baseline to the final on-therapy visit for - WOMAC pain subscale score; WOMAC physical function subscale score; and subject's average global assessment of response to therapy through the final on-therapy visit
Secondary outcomes (1)
Average change from baseline to final on-therapy visit for WOMAC stiffness subscale score; average change from baseline to final on-therapy visit for total WOMAC Index; average number of propoxyphene HCl rescue medication capsules per day while in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startApr 2002
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial, Study director, McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240786
- Sponsor's protocol ID
- CR002485
- Status last verified
- Jun 2011
- First submitted
- 14 Oct 2005
- Last updated
- 29 Jun 2011
- Results posted
- No
Publications
Kuffner EK, Temple AR, Cooper KM, Baggish JS, Parenti DL. Retrospective analysis of transient elevations in alanine aminotransferase during long-term treatment with acetaminophen in osteoarthritis clinical trials. Curr Med Res Opin. 2006 Nov;22(11):2137-48. doi: 10.1185/030079906x148346.
PubMed 17076974
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Acetaminophen Extended Release (1950 mg/Day or 3900 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee
- ClinicalTrials.gov ID
- NCT00240786
- Acronym / sponsor ID
- CR002485
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis hip, osteoarthritis knee, acetaminophen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Study completion
- Mar 2003 (actual)
- First posted
- 18 Oct 2005 (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.
The purpose of this study is to determine the safety and effectiveness of 650 mg and 1300 mg acetaminophen extended release given three times a day for the relief of signs and symptoms of osteoarthritis of the hip or knee for a period of 12 weeks.
Detailed description
This is a randomized, double-blind, placebo-controlled study to determine the safety and effectiveness of 650 mg and 1300 mg acetaminophen extended release given three times a day as compared with placebo, for the relief of signs and symptoms of osteoarthritis of the hip or knee for a period of 12 weeks. Propoxyphene Hydrochloride capsules 65 mg are used as rescue medication if subjects experience inadequate pain relief. The primary efficacy assessments are the average change from baseline to the final on-therapy visit for the WOMAN pain subscale score and the WOMAC physical function subscale scare, and the subject's average global assessment of their response to therapy through the final on-therapy visit. Safety assessments at study visits consist of monitoring adverse events, vital signs, study joint assessments and clinical laboratory determinations. The hypothesis is that 1950 mg per day and/or 3900 mg per day acetaminophen extended release are superior to placebo for the relief of the signs and symptoms of osteoarthritis of the hip or knee with respect to all three primary efficacy endpoints. Treatment consisted of either one 650 mg acetaminophen extended release caplet plus one placebo caplet (acetaminophen 1950 mg group); two 650 mg acetaminophen extended release caplets (acetaminophen 3900 mg group); or two placebo caplets administered orally every eight hours for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptomats of osteoarthritis of the hip or knee for a minimum of six months
- History of hip or knee pain due to osteoarthritis requiring the use of NSAIDs, acetaminophen, or another analgesic agent on a regular basis (>= three days per week) for at least three months before the screening visit
- History of positive therapeutic benefit with acetaminophen use for osteoarthritis pain
- History of osteoarthritis pain (moderate, moderately severe, or severe) of the hip or knee when not taking osteoarthritis analgesic medication
- Must have a pain level of moderate or moderately severe for 24 hours over the previous 24 hours prior to the baseline visit, and at baseline, demonstrate a 20% or greater increase in the pain subscale score, relative to the score at screening
Key exclusion criteria (4 listed)
- History of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit
- Grade 1 or grade 4 severity of the study joint based on the Kellgren and Lawrence radiographic criteria
- Maximum osteoarthritis pain intensity of none, mild or severe experienced over the previous 24 hours of the baseline visit
- Signs of clinically important active inflammation of the study knee joint including redness, warmth and/or a large, bulging effusion with the loss of normal contour at the screening and/or baseline visits
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 |
|---|---|---|
| acetaminophen extended release | Drug | – |
Primary outcome
Average change from baseline to the final on-therapy visit for - WOMAC pain subscale score; WOMAC physical function subscale score; and subject's average global assessment of response to therapy through the final on-therapy visit
1 secondary outcome
Average change from baseline to final on-therapy visit for WOMAC stiffness subscale score; average change from baseline to final on-therapy visit for total WOMAC Index; average number of propoxyphene HCl rescue medication capsules per day while in study
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 29 Jun 2011.
- Derived from this study: PubMed 17076974Kuffner EK, Temple AR, Cooper KM, Baggish JS, Parenti DL. Retrospective analysis of transient elevations in alanine aminotransferase during long-term treatment with acetaminophen in osteoarthritis clinical trials. Curr Med Res Opin. 2006 Nov;22(11):2137-48. doi: 10.1185/030079906x148346.
- An Effectiveness and Safety Study of Two Doses of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or KneeLink provided by the sponsor.
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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.
McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial study director
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acetaminophen extended release in people with Osteoarthritis, 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 4 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 29 Jun 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?
Average change from baseline to the final on-therapy visit for - WOMAC pain subscale score; WOMAC physical function subscale score; and subject's average global assessment of response to therapy through the final on-therapy visit. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00240786, which also lists 1 linked publication.
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 29 Jun 2011.