ArthroscopyPhase 4NCT00633438
Effect of Celecoxib Versus Placebo Before and After Knee Surgery on Overall Use of Analgesics After Surgery
A Phase 4 study testing Celecoxib in people with Arthroscopy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 18 sites in United States.
Trial summary
To compare total analgesic use at 24 hours after arthroscopic knee surgery in celecoxib-treated versus placebo-treated patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arthroscopy
- What is being tested?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 18 sitesUnited States
- Study dates
- Jan 2004to Jun 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed (or suspected to have) meniscus trauma of the knee requiring ambulatory arthroscopic knee surgery
- Willing to participate in study for 36 hours and come to follow-up visit 7 days post surgery
Who cannot join
- Osteoarthritis, inflammatory arthritis, or previous fracture of index joint
- Received acetaminophen or low dose narcotic (vicodin/tylox) within 8 hours of surgery
- Have received oral (4 weeks), intramuscular (2 months), intra-articular (3 months) or soft-tissue (2 months) injections of corticosteroids of the first dose of study medication or intra-artcular injections of hyaluronic acid in the index joint within 9 months of the first dose of study medication
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Pfizer Investigational Site
Baltimore, Maryland, 21218
Pfizer Investigational Site
Columbia, South Carolina, 29202
Pfizer Investigational Site
Columbia, South Carolina, 29204
Pfizer Investigational Site
Columbia, South Carolina, 29212
Pfizer Investigational Site
Johnson City, Tennessee, 37601
Pfizer Investigational Site
Orangeburg, South Carolina, 29110
Pfizer Investigational Site
Phoenix, Arizona, 85023
Pfizer Investigational Site
San Antonio, Texas, 78205
Pfizer Investigational Site
San Antonio, Texas, 78209
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Antonio, Texas, 78240
Pfizer Investigational Site
Springfield, Massachusetts, 01104
Pfizer Investigational Site
Springfield, Massachusetts, 01107
Pfizer Investigational Site
Springfield, Massachusetts, 01109
Pfizer Investigational Site
Springfield, Massachusetts, 01199
Pfizer Investigational Site
Springfield, Missouri, 65807
Pfizer Investigational Site
St. Petersburg, Florida, 33713
Pfizer Investigational Site
Timonium, Maryland, 21093
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized Comparison Study of the Efficacy of Celebrex 400 mg Single Dose Pre and Celebrex 200 mg Post Ambulatory Arthroscopic Knee Surgery for Total Analgesic Use After Surgery
To compare total analgesic use at 24 hours after arthroscopic knee surgery in celecoxib-treated versus placebo-treated patients
- Conditions
- Arthroscopy
- Being tested
- Placebo, Celecoxib
- Keywords
- Knee Surgery Arthroscopic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Matched oral capsule administered 1 hour prior to surgery and matched oral capsule administered post surgery as needed
CelecoxibDrug
400 mg oral capsule as single dose administered 1 hour prior to surgery and 200 mg oral capsule as single dose administered post surgery as needed
| Study group | Role | What they receive |
|---|---|---|
| B | Placebo comparator | Not described Receives: Other: Placebo |
| A | Experimental | Not described Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total analgesic use (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery
Measured: 24 hours
Secondary outcomes (7)
Patient Assessment of Pain, according to visual analogue scale, after surgery at rest and flexion
Measured: 1, 2, 6, 8, 10, 12, 24, 36 hours
Time to analgesic use after surgery
Measured: 1, 2, 6, 8, 10, 12, 24, 36 hours
Number and percentage of patients taking HC/APAP after surgery
Measured: 1, 2, 6, 8, 10, 12, 24, 36 hours
Adverse events
Measured: Day 7
Physical exam
Measured: Day 7
Vital signs
Measured: Day 7
Laboratory evaluation
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startJan 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroscopyStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633438
- Sponsor's protocol ID
- A3191067
- Status last verified
- Feb 2021
- First submitted
- 4 Mar 2008
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized Comparison Study of the Efficacy of Celebrex 400 mg Single Dose Pre and Celebrex 200 mg Post Ambulatory Arthroscopic Knee Surgery for Total Analgesic Use After Surgery
- ClinicalTrials.gov ID
- NCT00633438
- Acronym / sponsor ID
- A3191067
- Conditions
- Arthroscopy
- Keywords
- Knee Surgery Arthroscopic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Jun 2004 (actual)
- First posted
- 12 Mar 2008 (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.
To compare total analgesic use at 24 hours after arthroscopic knee surgery in celecoxib-treated versus placebo-treated patients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Placebo comparator | Other: Placebo |
| A | Experimental | Drug: Celecoxib |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed (or suspected to have) meniscus trauma of the knee requiring ambulatory arthroscopic knee surgery
- Willing to participate in study for 36 hours and come to follow-up visit 7 days post surgery
Key exclusion criteria (3 listed)
- Osteoarthritis, inflammatory arthritis, or previous fracture of index joint
- Received acetaminophen or low dose narcotic (vicodin/tylox) within 8 hours of surgery
- Have received oral (4 weeks), intramuscular (2 months), intra-articular (3 months) or soft-tissue (2 months) injections of corticosteroids of the first dose of study medication or intra-artcular injections of hyaluronic acid in the index joint within 9 months of the first dose of study medication
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 |
|---|---|---|
| PlaceboMatched oral capsule administered 1 hour prior to surgery and matched oral capsule administered post surgery as needed | Other | B |
| Celecoxib400 mg oral capsule as single dose administered 1 hour prior to surgery and 200 mg oral capsule as single dose administered post surgery as needed | Drug | A |
Primary outcome
Total analgesic use (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery
Time frame: 24 hours
7 secondary outcomes
Patient Assessment of Pain, according to visual analogue scale, after surgery at rest and flexion
Time frame: 1, 2, 6, 8, 10, 12, 24, 36 hours
Time to analgesic use after surgery
Time frame: 1, 2, 6, 8, 10, 12, 24, 36 hours
Number and percentage of patients taking HC/APAP after surgery
Time frame: 1, 2, 6, 8, 10, 12, 24, 36 hours
Adverse events
Time frame: Day 7
Physical exam
Time frame: Day 7
Vital signs
Time frame: Day 7
Laboratory evaluation
Time frame: Day 7
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 21 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Celecoxib in people with Arthroscopy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 18 sites in United States.
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 2 inclusion and 3 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. 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. Some participants in this study may receive a placebo. 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 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 analgesic use (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery (time frame: 24 hours). 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 21 Feb 2021.