PainPhase 4NCT00140920
A Study of Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement (0966-259)
A Phase 4 study testing MK0966; rofecoxib and Comparator: diclofenac 2x 75 mg in people with Pain, run by Merck Sharp & Dohme LLC.
Trial summary
A study to compare pre-operative administration of rofecoxib versus post-operative administration of diclofenac or rofecoxib, respectively, in the treatment of post-operative pain after total knee joint replacement in patients with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- MK0966; rofecoxib and Comparator: diclofenac 2x 75 mg
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2004to 27 Sep 2004
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females at least 18 years of age who have osteoarthritis of the knee and have undergone total knee joint replacement.
Who cannot join
None listed.
About this study
Official title: A Study to Compare Pre-Operative Administration of Rofecoxib Vs Post-Operative Administration of Diclofenac or Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement in Patients With Osteoarthritis of the Knee.
A study to compare pre-operative administration of rofecoxib versus post-operative administration of diclofenac or rofecoxib, respectively, in the treatment of post-operative pain after total knee joint replacement in patients with osteoarthritis of the knee.
- Conditions
- Pain
- Being tested
- MK0966; rofecoxib, Comparator: diclofenac 2x 75 mg
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0966; rofecoxibDrug
Comparator: diclofenac 2x 75 mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of patient controlled
Post-operative morphine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study start25 May 2004
- Primary completion27 Sep 2004
- Study completion27 Sep 2004
Why it stopped: Recruitment/study discontinued after withdrawal of marketing authorisation. No data entered.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 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
- NCT00140920
- Sponsor's protocol ID
- 0966-259
- Other IDs
- 2005_054
- Status last verified
- May 2017
- First submitted
- 30 Aug 2005
- Last updated
- 9 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare Pre-Operative Administration of Rofecoxib Vs Post-Operative Administration of Diclofenac or Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement in Patients With Osteoarthritis of the Knee.
- ClinicalTrials.gov ID
- NCT00140920
- Acronym / sponsor ID
- 0966-259
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment/study discontinued after withdrawal of marketing authorisation. No data entered.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 25 May 2004 (actual)
- Primary completion
- 27 Sep 2004 (actual)
- Study completion
- 27 Sep 2004 (actual)
- First posted
- 1 Sep 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.
A study to compare pre-operative administration of rofecoxib versus post-operative administration of diclofenac or rofecoxib, respectively, in the treatment of post-operative pain after total knee joint replacement in patients with osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males or females at least 18 years of age who have osteoarthritis of the knee and have undergone total knee joint replacement.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MK0966; rofecoxib | Drug | – |
| Comparator: diclofenac 2x 75 mg | Drug | – |
Primary outcome
Quantity of patient controlled
Post-operative morphine administration
Results and safety
The study was stopped early (reason given: Recruitment/study discontinued after withdrawal of marketing authorisation. No data entered.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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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 4 study testing MK0966; rofecoxib and Comparator: diclofenac 2x 75 mg in people with Pain, 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 1 inclusion and 0 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 9 May 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 (reason given: Recruitment/study discontinued after withdrawal of marketing authorisation. No data entered.). 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?
Quantity of patient controlled. The study lists 2 primary outcomes in all. 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 9 May 2017.