Pain, PostoperativePhase 4NCT00650598
A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy for Anterior Cruciate Ligament (ACL) Reconstruction
A Phase 4 study testing valdecoxib and diclofenac in people with Pain, Postoperative, run by Pfizer at 25 sites in 10 countries.
Trial summary
To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac sodium delayed release 75 mg BID in analgesic efficacy, in subjects undergoing knee arthroscopy procedure for anterior cruciate ligament… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- valdecoxib and diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 25 sitesin 10 countries
- Study dates
- Mar 2004to Aug 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
- Patients who had undergone an uncomplicated ACL reconstruction procedure and were in satisfactory health were included in the study
- In addition, they needed to have a baseline pain intensity of ≥ 50 mm on the VAS and "moderate to severe" pain on the categorical scale within 8 hours of the completion of the surgical procedure to be included
Who cannot join
- Patient was scheduled to undergo any other surgical procedure, along with the orthopedic procedure, that was expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
- The patient was undergoing bilateral knee arthroscopy
- The patient used conventional NSAIDs, COX-2 inhibitors, or Tramadol during the 6 hours preceding surgery, during surgery or subsequent to the end of surgery, until randomization
- The patient received oxaprozin or piroxicam within one week prior to randomization
- The patient was required to take muscle relaxants, tricyclic antidepressants, tranquilizers, sedatives, hypnotics and neuroleptics, in the post operative period after the patient was randomized into the study
- The patient had been treated with patient controlled analgesia subsequent to the end of the surgical procedure
Trial locations and contacts
25 sites in 10 countries.
25 sites in 10 countries
South Korea4 sites
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 138-736
Pfizer Investigational Site
Seoul, 140-757
Pfizer Investigational Site
Seoul
Thailand4 sites
Pfizer Investigational Site
Bangkok, 10330
Pfizer Investigational Site
Bangkok, 10400
Pfizer Investigational Site
Bangkok, 10700
Pfizer Investigational Site
Bangkok
Malaysia3 sites
Pfizer Investigational Site
Cheras, Kuala Lumpur, 56000
Pfizer Investigational Site
Kuala Lumpur, Kuala Lumpur, 50586
Pfizer Investigational Site
Kuala Lumpur, Kuala Lumpur, 59100
New Zealand3 sites
Pfizer Investigational Site
Auckland
Pfizer Investigational Site
Christchurch
Pfizer Investigational Site
Wellington
Philippines3 sites
Pfizer Investigational Site
Manila
Pfizer Investigational Site
Quezon
Pfizer Investigational Site
Quezon City
Taiwan3 sites
Pfizer Investigational Site
Kaohsiung City
Pfizer Investigational Site
Keelung
Pfizer Investigational Site
Taipei
Hong Kong2 sites
Pfizer Investigational Site
Hong Kong
Pfizer Investigational Site
Shatin, New Territories
Australia1 site
Pfizer Investigational Site
Adelaide, South Australia, SA 5000
Location not given1 site
Pfizer Investigational Site
About this study
Official title: A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy Procedure for Anterior Cruciate Ligament Reconstruction
To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac sodium delayed release 75 mg BID in analgesic efficacy, in subjects undergoing knee arthroscopy procedure for anterior cruciate ligament (ACL) reconstruction, when administered for 6 (±1) days.
- Conditions
- Pain, Postoperative
- Being tested
- valdecoxib, diclofenac
- Keywords
- anterior cruciate ligament, arthroscopy, knee, post-surgical pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valdecoxibDrug
valdecoxib 40 mg (two 20-mg tablets) loading dose by mouth on Day 1 followed by 20 mg twice daily (BID) on Days 2-6
diclofenacDrug
diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: valdecoxib |
| Arm 2 | Active comparator | Not described Receives: Drug: diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Assessment of Pain - Visual Analogue Scale
Measured: Days 1-6
Secondary outcomes (7)
Physical examination
Measured: Screening and Day 6
Global Evaluation of Study Medication
Measured: Days 1-6
Consumption of Rescue Medication
Measured: Days 1-6
Modified Brief Pain Inventory - short form
Measured: Days 2-6
Adverse events
Measured: Days 1-6
Vital signs
Measured: Screening, Day 1, and Day 6
Effect on Pain Medication Questionnaire and Health Resource Utilization
Measured: Days 2-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startMar 2004
- Primary completionAug 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650598
- Sponsor's protocol ID
- A3471039
- Status last verified
- Oct 2008
- First submitted
- 31 Mar 2008
- Last updated
- 8 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy Procedure for Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT00650598
- Acronym / sponsor ID
- A3471039
- Conditions
- Pain, Postoperative
- Keywords
- anterior cruciate ligament, arthroscopy, knee, post-surgical pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 2 Apr 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 demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac sodium delayed release 75 mg BID in analgesic efficacy, in subjects undergoing knee arthroscopy procedure for anterior cruciate ligament (ACL) reconstruction, when administered for 6 (±1) days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: valdecoxib |
| Arm 2 | Active comparator | Drug: diclofenac |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who had undergone an uncomplicated ACL reconstruction procedure and were in satisfactory health were included in the study
- In addition, they needed to have a baseline pain intensity of ≥ 50 mm on the VAS and "moderate to severe" pain on the categorical scale within 8 hours of the completion of the surgical procedure to be included
Key exclusion criteria (6 listed)
- Patient was scheduled to undergo any other surgical procedure, along with the orthopedic procedure, that was expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
- The patient was undergoing bilateral knee arthroscopy
- The patient used conventional NSAIDs, COX-2 inhibitors, or Tramadol during the 6 hours preceding surgery, during surgery or subsequent to the end of surgery, until randomization
- The patient received oxaprozin or piroxicam within one week prior to randomization
- The patient was required to take muscle relaxants, tricyclic antidepressants, tranquilizers, sedatives, hypnotics and neuroleptics, in the post operative period after the patient was randomized into the study
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 |
|---|---|---|
| valdecoxibvaldecoxib 40 mg (two 20-mg tablets) loading dose by mouth on Day 1 followed by 20 mg twice daily (BID) on Days 2-6 | Drug | Arm 1 |
| diclofenacdiclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days | Drug | Arm 2 |
Primary outcome
Patient Assessment of Pain - Visual Analogue Scale
Time frame: Days 1-6
7 secondary outcomes
Physical examination
Time frame: Screening and Day 6
Global Evaluation of Study Medication
Time frame: Days 1-6
Consumption of Rescue Medication
Time frame: Days 1-6
Modified Brief Pain Inventory - short form
Time frame: Days 2-6
Adverse events
Time frame: Days 1-6
Vital signs
Time frame: Screening, Day 1, and Day 6
Effect on Pain Medication Questionnaire and Health Resource Utilization
Time frame: Days 2-6
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 8 Oct 2008.
- 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
25 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valdecoxib and diclofenac in people with Pain, Postoperative, run by Pfizer at 25 sites in 10 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 2 inclusion and 6 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 8 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in South Korea, Thailand, Malaysia, New Zealand, Philippines and 4 more countries. 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 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?
Patient Assessment of Pain - Visual Analogue Scale (time frame: Days 1-6). 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 8 Oct 2008.