OsteoarthritisPhase 2NCT00242489
Etoricoxib in the Treatment of Osteoarthritis (MK-0663-007)
A Phase 2 study testing MK0663, etoricoxib / Duration of Treatment: Part I (6 weeks), Part II (8 weeks) in people with Osteoarthritis, run by Organon and Co.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of etoricoxib in 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
- What is being tested?
- MK0663, etoricoxib / Duration of Treatment: Part I (6 weeks), Part II (8 weeks)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,167 participants
- Where
- No sites listed yet
- Study dates
- Jun 1998to Jul 2002
- Phase
- Phase 2
- 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
- At least 40 years of age with a clinical diagnosis of Osteoarthritis (OA)of the knee for 6 months prior to study entry (ARA class I, II, or III).
- Positive therapeutic effect from prior NSAID therapy.
- Worsening of symptoms upon withdrawal of prior treatment.
- With the exception of OA, in otherwise good health
Who cannot join
- Weight no more than 280 pounds (male or female).
- Recent, sustained use of gastroprotective agents.
- History of arthroscopy of the affected knee within 6 months prior to study entry.
- History of acute ligamentous or meniscal injury of the study joint within the previous 2 years.
About this study
Official title: A Placebo-Controlled, Parallel-Group, Double-Blind Study to Assess Safety and to Define the Clinically Effective Dose Range of MK0663 in Patients With Osteoarthritis of the Knee, Followed by a Double-Blind, Active-Comparator-Controlled Extension.
The purpose of this study is to evaluate the safety and efficacy of etoricoxib in the treatment of osteoarthritis of the knee.
- Conditions
- Osteoarthritis
- Being tested
- MK0663, etoricoxib / Duration of Treatment: Part I (6 weeks), Part II (8 weeks), Placebo;Diclofenac 50mg(tid)/Duration of Treatment: Part I (Placebo) 6 weeks;Part II (Diclofenac) 8 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: Part I (6 weeks), Part II (8 weeks)Drug
Placebo;Diclofenac 50mg(tid)/Duration of Treatment: Part I (Placebo) 6 weeks;Part II (Diclofenac) 8 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC Pain Subscale, Investigator Global Assessment of Disease Status, and Patient Global Assessment of Response to Therapy (not a primary endpoint in extension periods)
Secondary outcomes (1)
Physical Function Subscale (WOMAC), Stiffness Subscale (WOMAC), Patient Global Assessment of Disease Status, Investigator Global Assessment of Response to Therapy , Proportion of Patients Discontinued Due to Lack of Efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startJun 1998
- Primary completionFeb 1999
- Study completionJul 2002
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,167 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
- NCT00242489
- Sponsor's protocol ID
- 0663-007
- Other IDs
- 2005_088
- Status last verified
- Feb 2022
- First submitted
- 18 Oct 2005
- Last updated
- 18 Feb 2022
- Results posted
- No
Publications
Gottesdiener K, Schnitzer T, Fisher C, Bockow B, Markenson J, Ko A, DeTora L, Curtis S, Geissler L, Gertz BJ; Protocol 007 Study Group. Results of a randomized, dose-ranging trial of etoricoxib in patients with osteoarthritis. Rheumatology (Oxford). 2002 Sep;41(9):1052-61. doi: 10.1093/rheumatology/41.9.1052.
PubMed 12209041Curtis SP, Bockow B, Fisher C, Olaleye J, Compton A, Ko AT, Reicin AS. Etoricoxib in the treatment of osteoarthritis over 52-weeks: a double-blind, active-comparator controlled trial [NCT00242489]. BMC Musculoskelet Disord. 2005 Dec 1;6:58. doi: 10.1186/1471-2474-6-58.
PubMed 16321158
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Parallel-Group, Double-Blind Study to Assess Safety and to Define the Clinically Effective Dose Range of MK0663 in Patients With Osteoarthritis of the Knee, Followed by a Double-Blind, Active-Comparator-Controlled Extension.
- ClinicalTrials.gov ID
- NCT00242489
- Acronym / sponsor ID
- 0663-007
- Conditions
- Osteoarthritis
- Keywords
- Arcoxia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,167 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jun 1998
- Primary completion
- Feb 1999 (actual)
- Study completion
- Jul 2002 (actual)
- First posted
- 20 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 evaluate the safety and efficacy of etoricoxib in the treatment of osteoarthritis of the knee.
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 (4 listed)
- At least 40 years of age with a clinical diagnosis of Osteoarthritis (OA)of the knee for 6 months prior to study entry (ARA class I, II, or III).
- Positive therapeutic effect from prior NSAID therapy.
- Worsening of symptoms upon withdrawal of prior treatment.
- With the exception of OA, in otherwise good health
Key exclusion criteria (4 listed)
- Weight no more than 280 pounds (male or female).
- Recent, sustained use of gastroprotective agents.
- History of arthroscopy of the affected knee within 6 months prior to study entry.
- History of acute ligamentous or meniscal injury of the study joint within the previous 2 years.
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: Part I (6 weeks), Part II (8 weeks) | Drug | – |
| Placebo;Diclofenac 50mg(tid)/Duration of Treatment: Part I (Placebo) 6 weeks;Part II (Diclofenac) 8 weeks | Drug | – |
Primary outcome
WOMAC Pain Subscale, Investigator Global Assessment of Disease Status, and Patient Global Assessment of Response to Therapy (not a primary endpoint in extension periods)
1 secondary outcome
Physical Function Subscale (WOMAC), Stiffness Subscale (WOMAC), Patient Global Assessment of Disease Status, Investigator Global Assessment of Response to Therapy , Proportion of Patients Discontinued Due to Lack of Efficacy
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 18 Feb 2022.
- Background: PubMed 12209041Gottesdiener K, Schnitzer T, Fisher C, Bockow B, Markenson J, Ko A, DeTora L, Curtis S, Geissler L, Gertz BJ; Protocol 007 Study Group. Results of a randomized, dose-ranging trial of etoricoxib in patients with osteoarthritis. Rheumatology (Oxford). 2002 Sep;41(9):1052-61. doi: 10.1093/rheumatology/41.9.1052.
- Results publication: PubMed 16321158Curtis SP, Bockow B, Fisher C, Olaleye J, Compton A, Ko AT, Reicin AS. Etoricoxib in the treatment of osteoarthritis over 52-weeks: a double-blind, active-comparator controlled trial [NCT00242489]. BMC Musculoskelet Disord. 2005 Dec 1;6:58. doi: 10.1186/1471-2474-6-58.
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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 2 study testing MK0663, etoricoxib / Duration of Treatment: Part I (6 weeks), Part II (8 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 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 18 Feb 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
WOMAC Pain Subscale, Investigator Global Assessment of Disease Status, and Patient Global Assessment of Response to Therapy (not a primary endpoint in extension periods). 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 NCT00242489, 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 18 Feb 2022.