OsteoarthritisPhase 2NCT00397683
A 52-Week Study to Assess the Effects of MK0822 on Knee Osteoarthritis (MK-0822-011)
A Phase 2 study testing MK0822 in people with Osteoarthritis, run by Merck Sharp & Dohme LLC at 16 sites in 5 countries.
Trial summary
The purpose of this study is to test MK0822 on disease activity in patients with osteoarthritis in the knee. Disease modifying activity of MK0822 will be assessed by measurements of knee cartilage using Magnetic Resonance Imaging (MRI) 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?
- MK0822
- How many people
- 2 participants
- Where
- 16 sitesin 5 countries
- Study dates
- Oct 2006to Apr 2007
- 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
- Patients with symptomatic knee osteoarthritis for at least 6 months based on clinical and radiographic criteria
- Patients should be in general good health and must have a certain level of knee pain or be taking pain medicines on most days
- Specific radiographic (X-ray) and MRI features must also be satisfied
Who cannot join
- Non-osteoarthritic causes of knee pain
- Ineligibility to undergo MRI of the knee due to patient tolerability or safety reasons
- Previous septic arthritis, tibial osteotomy or knee replacement in both knees
- Acute injury of knee ligaments or meniscus in past 2 years
- Knee arthroscopy in past 12 months
- Anticipated arthroscopy or surgery in next 18 months
Show all 9Show fewer
- Use of intra-articular injections of hyaluronan (e.g. Hyalgan (TM), Synvisc (TM), Orthovisc (TM)) in past 6 months, or injections of glucocorticoids (e.g. Kenalog (TM), Aristospan (TM), Depo-Medrol (TM)) in past 3 months or anticipated knee injections during the study
- Glucosamine or chondroitin sulfate are allowable if they are at a stable dose for past 3 months and will continue at that dose during the study
- Other exclusion criteria apply-Please ask the study doctor for details
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
United States12 sites
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Coral Gables, Florida, 33134
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Hialeah, Florida, 33010
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Norristown, Pennsylvania, 19401
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Palm Desert, California, 92260
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Perkasie, Pennsylvania, 18944
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Pomona, California, 91767
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Rochester, New York, 14168
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Rochester, New York, 14609
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Rochester, New York, 14618
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South Miami, Florida, 33143-0000
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Torrance, California, 90505
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Upland, California, 91786
About this study
Official title: Proprietary Information - Exploratory (Non-Confirmatory) Trial
The purpose of this study is to test MK0822 on disease activity in patients with osteoarthritis in the knee. Disease modifying activity of MK0822 will be assessed by measurements of knee cartilage using Magnetic Resonance Imaging (MRI) of the knee.
This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).
- Conditions
- Osteoarthritis
- Being tested
- MK0822
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0822Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Secondary outcomes (1)
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- 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
- NCT00397683
- Sponsor's protocol ID
- 0822-011
- Other IDs
- 2006_517
- Status last verified
- Oct 2015
- First submitted
- 8 Nov 2006
- Last updated
- 2 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proprietary Information - Exploratory (Non-Confirmatory) Trial
- ClinicalTrials.gov ID
- NCT00397683
- Acronym / sponsor ID
- 0822-011
- Conditions
- Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 9 Nov 2006 (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 test MK0822 on disease activity in patients with osteoarthritis in the knee. Disease modifying activity of MK0822 will be assessed by measurements of knee cartilage using Magnetic Resonance Imaging (MRI) of the knee.
This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).
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 (3 listed)
- Patients with symptomatic knee osteoarthritis for at least 6 months based on clinical and radiographic criteria
- Patients should be in general good health and must have a certain level of knee pain or be taking pain medicines on most days
- Specific radiographic (X-ray) and MRI features must also be satisfied
Key exclusion criteria (9 listed)
- Non-osteoarthritic causes of knee pain
- Ineligibility to undergo MRI of the knee due to patient tolerability or safety reasons
- Previous septic arthritis, tibial osteotomy or knee replacement in both knees
- Acute injury of knee ligaments or meniscus in past 2 years
- Knee arthroscopy in past 12 months
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 |
|---|---|---|
| MK0822 | Drug | – |
Primary outcome
Proprietary Information - Exploratory (Non-Confirmatory) Trial
1 secondary outcome
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
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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
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK0822 in people with Osteoarthritis, run by Merck Sharp & Dohme LLC at 16 sites in 5 countries.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Chile, Colombia, Mexico, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early. Results are not available in the source record.
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?
Proprietary Information - Exploratory (Non-Confirmatory) Trial. 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 2 Nov 2015.