OsteoarthritisPhase 2NCT00296569
A Study to Assess the Safety and Efficacy of an Investigational Drug (MK-686) in Patients With Osteoarthritis (0686-006)
A Phase 2 study testing MK0686 in people with Osteoarthritis, run by Merck Sharp & Dohme LLC.
Trial summary
This study is being conducted to assess the safety and tolerability of MK-0686 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 to 65 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- MK0686
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to May 2006
- 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 to 65 years
- 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 ARA functional class I,II or III and with no clinically significant diseases
- 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
- females must be either post-menopausal or surgically sterilized
Who cannot join
- No history of concurrent arthritic disease
- No history of neoplastic disease within a specified duration
- No history of disease that causes malabsorption
- Chronic use of certain medications excluded
About this study
Official title: A 4-Week, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of MK0686 in Patients With Osteoarthritis of the Knee or Hip
This study is being conducted to assess the safety and tolerability of MK-0686 and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.
- Conditions
- Osteoarthritis
- Being tested
- MK0686
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0686Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief at the knee and hip over 4 weeks of treatment as assessed by the WOMAC Pain Subscale.
Measured: over 4 weeks of treatment
Secondary outcomes (1)
Safety and tolerability over a 4-week treatment period
Measured: over a 4-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startSep 2005
- Primary completionMay 2006
- Study completionMay 2006
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
- Who is masked
- Participant, Investigator
- Enrolment
- 150 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
- NCT00296569
- Sponsor's protocol ID
- 0686-006
- Other IDs
- MK0686-006, 2006_011
- Status last verified
- Dec 2014
- First submitted
- 24 Feb 2006
- Last updated
- 24 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Week, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of MK0686 in Patients With Osteoarthritis of the Knee or Hip
- ClinicalTrials.gov ID
- NCT00296569
- Acronym / sponsor ID
- 0686-006
- Conditions
- Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 27 Feb 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.
This study is being conducted to assess the safety and tolerability of MK-0686 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 to 65 years
- 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 ARA functional class I,II or III and with no clinically significant diseases
- 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
- females must be either post-menopausal or surgically sterilized
Key exclusion criteria (4 listed)
- No history of concurrent arthritic disease
- No history of neoplastic disease within a specified duration
- No history of disease that causes malabsorption
- Chronic use of certain medications excluded
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 |
|---|---|---|
| MK0686 | Drug | – |
Primary outcome
Pain relief at the knee and hip over 4 weeks of treatment as assessed by the WOMAC Pain Subscale.
Time frame: over 4 weeks of treatment
1 secondary outcome
Safety and tolerability over a 4-week treatment period
Time frame: over a 4-week treatment period
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 24 Dec 2014.
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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 MK0686 in people with Osteoarthritis, run by Merck Sharp & Dohme LLC.
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 24 Dec 2014. 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?
Pain relief at the knee and hip over 4 weeks of treatment as assessed by the WOMAC Pain Subscale. (time frame: over 4 weeks of treatment). 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 24 Dec 2014.