Pain, Postoperative ArthroscopyPhase 3NCT00390260
Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)
A Phase 3 study testing MK0966 / Duration of Treatment: 1 Days and Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days in people with Pain, Postoperative Arthroscopy, run by Merck Sharp & Dohme LLC.
Trial summary
Study the effect of rofecoxib 50 mg compared to both placebo, and hydrocodone 7.5 mg with acetaminophen 750 mg, to treat moderate to severe pain following arthroscopic knee surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain, Postoperative Arthroscopy
- What is being tested?
- MK0966 / Duration of Treatment: 1 Days and Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to Feb 2003
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Elective outpatient arthroscopic knee surgery expected to last <= 90 minutes using general anesthesia
- Patients must experience moderate to severe pain following surgery
- Patient must be in general good health as judged by the primary investigator
Who cannot join
- Osteoarthritis; rheumatoid arthritis
- Allergy/sensitivity to aspirin, ibuprofen, indomethacin, other NSAIDs, COX-2 inhibitors (e.g., rofecoxib, celecoxib), hydrocodone, acetaminophen
- Asthma associated with nasal polyps
- Any arthroscopic knee surgery in the past 6 months
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Rofecoxib 50 mg and Hydrocodone 7.5 mg With Acetaminophen 750 mg in Patients With Postoperative Arthroscopic Pain
Study the effect of rofecoxib 50 mg compared to both placebo, and hydrocodone 7.5 mg with acetaminophen 750 mg, to treat moderate to severe pain following arthroscopic knee surgery.
- Conditions
- Pain, Postoperative Arthroscopy
- Being tested
- MK0966 / Duration of Treatment: 1 Days, Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days, Comparator: placebo (unspecified) / Duration of Treatment: 1 Days
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0966 / Duration of Treatment: 1 DaysDrug
Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 DaysDrug
Comparator: placebo (unspecified) / Duration of Treatment: 1 DaysDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Pain Relief over 6 hours following a single oral dose compared to placebo.
Measured: 6 hours
Secondary outcomes (1)
Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startFeb 2002
- Primary completionFeb 2003
- Study completionFeb 2003
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 Pain, Postoperative ArthroscopyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 420 participants
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
- NCT00390260
- Sponsor's protocol ID
- 0966-179
- Other IDs
- 2006_535
- Status last verified
- Jan 2017
- First submitted
- 18 Oct 2006
- Last updated
- 2 Feb 2017
- Results posted
- No
Publications
Chelly JE, Nissen CW, Rodgers AJ, Smugar SS, Tershakovec AM. The efficacy of rofecoxib 50 mg and hydrocodone/acetaminophen 7.5/750 mg in patients with post-arthroscopic pain. Curr Med Res Opin. 2007 Jan;23(1):195-206. doi: 10.1185/030079907X162647.
PubMed 17207303
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Rofecoxib 50 mg and Hydrocodone 7.5 mg With Acetaminophen 750 mg in Patients With Postoperative Arthroscopic Pain
- ClinicalTrials.gov ID
- NCT00390260
- Acronym / sponsor ID
- 0966-179
- Conditions
- Pain, Postoperative Arthroscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 19 Oct 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.
Study the effect of rofecoxib 50 mg compared to both placebo, and hydrocodone 7.5 mg with acetaminophen 750 mg, to treat moderate to severe pain following arthroscopic knee surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Elective outpatient arthroscopic knee surgery expected to last <= 90 minutes using general anesthesia
- Patients must experience moderate to severe pain following surgery
- Patient must be in general good health as judged by the primary investigator
Key exclusion criteria (4 listed)
- Osteoarthritis; rheumatoid arthritis
- Allergy/sensitivity to aspirin, ibuprofen, indomethacin, other NSAIDs, COX-2 inhibitors (e.g., rofecoxib, celecoxib), hydrocodone, acetaminophen
- Asthma associated with nasal polyps
- Any arthroscopic knee surgery in the past 6 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 |
|---|---|---|
| MK0966 / Duration of Treatment: 1 Days | Drug | – |
| Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days | Drug | – |
| Comparator: placebo (unspecified) / Duration of Treatment: 1 Days | Drug | – |
Primary outcome
Total Pain Relief over 6 hours following a single oral dose compared to placebo.
Time frame: 6 hours
1 secondary outcome
Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen.
Time frame: 6 hours
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 2 Feb 2017.
- Background: PubMed 17207303Chelly JE, Nissen CW, Rodgers AJ, Smugar SS, Tershakovec AM. The efficacy of rofecoxib 50 mg and hydrocodone/acetaminophen 7.5/750 mg in patients with post-arthroscopic pain. Curr Med Res Opin. 2007 Jan;23(1):195-206. doi: 10.1185/030079907X162647.
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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 MK0966 / Duration of Treatment: 1 Days and Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days in people with Pain, Postoperative Arthroscopy, 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 3 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 2 Feb 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 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?
Total Pain Relief over 6 hours following a single oral dose compared to placebo. (time frame: 6 hours). 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 NCT00390260, 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 2 Feb 2017.