OsteoarthritisPhase 3NCT00542087
Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED)
A Phase 3 study testing MK0663, etoricoxib / Duration of Treatment: 6 Weeks and Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks in people with Osteoarthritis, run by Organon and Co.
Trial summary
To compare the safety and tolerability of etoricoxib and diclofenac sodium in the treatment of osteoarthritis of the knee or hip during a six week period. 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: 6 Weeks and Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks
- How many people
- 516 participants
- Where
- No sites listed yet
- Study dates
- 22 Mar 2002to 20 Dec 2002
- 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
- Patient is at least 40 years old and diagnosed with osteoarthritis of the knee or hip
- Has a history of treatment with NSAIDs with positive therapeutic benefit
- Agree to limit alcohol intake to less than 7 drinks per week and avoid unusual strenuous activity
- Females who are able to have children must have negative urine pregnancy tests
Who cannot join
- Has rheumatoid arthritis, lupus, Paget's disease affecting the study joint, or Wilson's disease
- History of acute ligament or meniscus damage to the study joint (knee or hip) within the past 2 years or arthroscopic surgery on the affected study joint with the past 6 months
- Requires joint replacement
About this study
Official title: A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Etoricoxib 60 mg and Diclofenac Sodium 150 mg in Patient With Osteoarthritis of the Knee or Hip
To compare the safety and tolerability of etoricoxib and diclofenac sodium in the treatment of osteoarthritis of the knee or hip during a six week period.
- Conditions
- Osteoarthritis
- Being tested
- MK0663, etoricoxib / Duration of Treatment: 6 Weeks, Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks
- 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: 6 WeeksDrug
Comparator: diclofenac sodium / Duration of Treatment: 6 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
This study will assess the effectiveness of the study drug vs. a comparator to treat successfully OA-related joint pain (judged by WOMAC pain subscale).
Secondary outcomes (1)
The study drug will be safe and well tolerated during the course of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study start22 Mar 2002
- Primary completion20 Dec 2002
- Study completion20 Dec 2002
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
- Who is masked
- Participant, Investigator
- Enrolment
- 516 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
- NCT00542087
- Sponsor's protocol ID
- 0663-805
- Other IDs
- 2007_625
- Status last verified
- Feb 2022
- First submitted
- 5 Oct 2007
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
Zacher J, Feldman D, Gerli R, Scott D, Hou SM, Uebelhart D, Rodger IW, Ozturk ZE; etoricoxib OA study group. A comparison of the therapeutic efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis. Curr Med Res Opin. 2003;19(8):725-36. doi: 10.1185/030079903125002469.
PubMed 14687444
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 Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Etoricoxib 60 mg and Diclofenac Sodium 150 mg in Patient With Osteoarthritis of the Knee or Hip
- ClinicalTrials.gov ID
- NCT00542087
- Acronym / sponsor ID
- 0663-805
- Conditions
- Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2002 (actual)
- Primary completion
- 20 Dec 2002 (actual)
- Study completion
- 20 Dec 2002 (actual)
- First posted
- 10 Oct 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 the safety and tolerability of etoricoxib and diclofenac sodium in the treatment of osteoarthritis of the knee or hip during a six week period.
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)
- Patient is at least 40 years old and diagnosed with osteoarthritis of the knee or hip
- Has a history of treatment with NSAIDs with positive therapeutic benefit
- Agree to limit alcohol intake to less than 7 drinks per week and avoid unusual strenuous activity
- Females who are able to have children must have negative urine pregnancy tests
Key exclusion criteria (3 listed)
- Has rheumatoid arthritis, lupus, Paget's disease affecting the study joint, or Wilson's disease
- History of acute ligament or meniscus damage to the study joint (knee or hip) within the past 2 years or arthroscopic surgery on the affected study joint with the past 6 months
- Requires joint replacement
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: 6 Weeks | Drug | – |
| Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks | Drug | – |
Primary outcome
This study will assess the effectiveness of the study drug vs. a comparator to treat successfully OA-related joint pain (judged by WOMAC pain subscale).
1 secondary outcome
The study drug will be safe and well tolerated during the course of the 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 15 Aug 2024.
- Background: PubMed 14687444Zacher J, Feldman D, Gerli R, Scott D, Hou SM, Uebelhart D, Rodger IW, Ozturk ZE; etoricoxib OA study group. A comparison of the therapeutic efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis. Curr Med Res Opin. 2003;19(8):725-36. doi: 10.1185/030079903125002469.
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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: 6 Weeks and Comparator: diclofenac sodium / Duration of Treatment: 6 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?
This study will assess the effectiveness of the study drug vs. a comparator to treat successfully OA-related joint pain (judged by WOMAC pain subscale).. 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 NCT00542087, 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 15 Aug 2024.