OsteoarthritisPhase 3NCT00269191
A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED)
A Phase 3 study testing MK0663, etoricoxib / Duration of Treatment 12 Weeks in people with Osteoarthritis, run by Organon and Co.
Trial summary
This study was conducted to assess the safety and tolerability of the drug and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- MK0663, etoricoxib / Duration of Treatment 12 Weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 528 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2003to 21 Nov 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
- Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee
- Either prior NSAID or Acetaminophen users within the the ARA functional class I,II or III
- Patients required to demonstrate a "flare" of the signs and symptoms of OA following withdrawal of NSAID treatment
- Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA.
Who cannot join
- No history of concurrent arthritic disease
- uncontrolled hypertension or an active cardiac condition
- No history of hepatitis, neoplastic disease, stroke or transient ischemic attack within a specified duration.
About this study
Official title: A 12-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Ibuprofen 2400 mg in Patients With Osteoarthritis (Study 1)
This study was conducted to assess the safety and tolerability of the drug and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.
- Conditions
- Osteoarthritis
- Being tested
- MK0663, etoricoxib / Duration of Treatment 12 Weeks, Placebo or Ibuprofen / Duration of Treatment 12 Weeks
- Keywords
- Arcoxia
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0663, etoricoxib / Duration of Treatment 12 WeeksDrug
Placebo or Ibuprofen / Duration of Treatment 12 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and physical function over 12-weeks as assessed by the WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status, as well as safety over 12-weeks as assessed by adverse experiences.
Secondary outcomes (1)
Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Disease Status, Stiffness, and Overall WOMAC scales as assessed over 12-weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study start5 Feb 2003
- Primary completion7 Nov 2003
- Study completion21 Nov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Who is masked
- Participant, Investigator
- Enrolment
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269191
- Sponsor's protocol ID
- 0663-071
- Other IDs
- 2005_110
- Status last verified
- Feb 2022
- First submitted
- 21 Dec 2005
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
Wiesenhutter CW, Boice JA, Ko A, Sheldon EA, Murphy FT, Wittmer BA, Aversano ML, Reicin AS; Protocol 071 Study Group. Evaluation of the comparative efficacy of etoricoxib and ibuprofen for treatment of patients with osteoarthritis: A randomized, double-blind, placebo-controlled trial. Mayo Clin Proc. 2005 Apr;80(4):470-9. doi: 10.4065/80.4.470.
PubMed 15819283Laine L, Curtis SP, Cryer B, Kaur A, Cannon CP; MEDAL Steering Committee. Assessment of upper gastrointestinal safety of etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. Lancet. 2007 Feb 10;369(9560):465-73. doi: 10.1016/S0140-6736(07)60234-7.
PubMed 17292766
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Ibuprofen 2400 mg in Patients With Osteoarthritis (Study 1)
- ClinicalTrials.gov ID
- NCT00269191
- Acronym / sponsor ID
- 0663-071
- Conditions
- Osteoarthritis
- Keywords
- Arcoxia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2003 (actual)
- Primary completion
- 7 Nov 2003 (actual)
- Study completion
- 21 Nov 2003 (actual)
- First posted
- 23 Dec 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.
This study was conducted to assess the safety and tolerability of the drug and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee
- Either prior NSAID or Acetaminophen users within the the ARA functional class I,II or III
- Patients required to demonstrate a "flare" of the signs and symptoms of OA following withdrawal of NSAID treatment
- Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA.
Key exclusion criteria (3 listed)
- No history of concurrent arthritic disease
- uncontrolled hypertension or an active cardiac condition
- No history of hepatitis, neoplastic disease, stroke or transient ischemic attack within a specified 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 |
|---|---|---|
| MK0663, etoricoxib / Duration of Treatment 12 Weeks | Drug | – |
| Placebo or Ibuprofen / Duration of Treatment 12 Weeks | Drug | – |
Primary outcome
Pain and physical function over 12-weeks as assessed by the WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status, as well as safety over 12-weeks as assessed by adverse experiences.
1 secondary outcome
Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Disease Status, Stiffness, and Overall WOMAC scales as assessed over 12-weeks.
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 15 Aug 2024.
- Background: PubMed 15819283Wiesenhutter CW, Boice JA, Ko A, Sheldon EA, Murphy FT, Wittmer BA, Aversano ML, Reicin AS; Protocol 071 Study Group. Evaluation of the comparative efficacy of etoricoxib and ibuprofen for treatment of patients with osteoarthritis: A randomized, double-blind, placebo-controlled trial. Mayo Clin Proc. 2005 Apr;80(4):470-9. doi: 10.4065/80.4.470.
- Background: PubMed 17292766Laine L, Curtis SP, Cryer B, Kaur A, Cannon CP; MEDAL Steering Committee. Assessment of upper gastrointestinal safety of etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. Lancet. 2007 Feb 10;369(9560):465-73. doi: 10.1016/S0140-6736(07)60234-7.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MK0663, etoricoxib / Duration of Treatment 12 Weeks in people with Osteoarthritis, run by Organon and Co.
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 4 inclusion and 3 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 15 Aug 2024. 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?
Pain and physical function over 12-weeks as assessed by the WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status, as well as safety over 12-weeks as assessed by adverse experiences.. 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 NCT00269191, which also lists 2 linked publications.
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 15 Aug 2024.