PainPhase 3NCT00650039

Double-Blind, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg Daily And Valdecoxib 20 Mg Twice Daily Compared To Placebo For Management Of Acute Postsurgical Pain In Anterior Cruciate Ligament (ACL) Reconstruction

A Phase 3 study testing valdecoxib in people with Pain, run by Pfizer at 81 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pain
What is being tested?: valdecoxib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 488 participants
Where: 81 sitesin 2 countries
Study dates: Mar 2004to Feb 2005
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Included patients had uncomplicated arthroscopic ACL reconstruction
Subjects were to have a Baseline pain intensity of ≥ 50 mm as measured on a 0 - 100mm visual analogue scale (VAS) and moderate to severe pain on a categorical scale by 23:00 hours on the day of surgery and prior to being discharged from the surgical facility
Subjects could not have received any medication or additional procedures that would confound the interpretation of the study results.

Who cannot join

the patient was admitted to or retained in the surgical center/hospital for >23 hours;
the patient underwent 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 used conventional nonsteroidal antiinflammatory drugs (NSAIDs), selective cyclooxygenase-2 (COX-2) inhibitors, or tramadol during the 6 hours preceding surgery, during surgery, or subsequent to the end of surgery;
the patient received oxaprozin or piroxicam within 1 week prior to randomization;
the patient had a pain pump or indwelling catheter during surgery that administered local or intraarticular anesthetics or narcotics at the index joint, or had such an intra-articular injection at the end of surgery;
the patient had been treated with patient-controlled analgesia or NSAIDs subsequent to the end of anesthesia;
patient had a history of clinically significant GI disease or renal disease, or history of a gastrointestinal ulcer, or cancer, or a laboratory abnormality that would suggest it was not in the subject's best interest to enroll in the trial.

Trial locations and contacts

81 sites in 2 countries.

Country

City, postcode or hospital

81 sites in 2 countries

United States68 sites

Pfizer Investigational Site
Anderson, South Carolina, 29621
Pfizer Investigational Site
Arlington, Virginia, 22205
Pfizer Investigational Site
Atlanta, Georgia, 30327
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Avon, Connecticut, 06001
Pfizer Investigational Site
Baltimore, Maryland, 21218
Pfizer Investigational Site
Bend, Oregon, 97701
Pfizer Investigational Site
Birmingham, Alabama, 35205
Pfizer Investigational Site
Birmingham, Alabama, 36205
Pfizer Investigational Site
Cedar Rapids, Iowa, 52401
Pfizer Investigational Site
Chicago, Illinois, 60304
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Cola, South Carolina, 29212
Pfizer Investigational Site
Columbia, South Carolina, 29202
Pfizer Investigational Site
Columbia, South Carolina, 29204
Pfizer Investigational Site
Cromwell, Connecticut, 06416
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Enfield, Connecticut, 06082
Pfizer Investigational Site
Fairfax, Virginia, 22031
Pfizer Investigational Site
Farmington, Connecticut, 06030
Pfizer Investigational Site
Farmington, Connecticut, 06032
Pfizer Investigational Site
Fort Worth, Texas, 76104
Pfizer Investigational Site
Fort Worth, Texas, 76107
Pfizer Investigational Site
Glastonbury, Connecticut, 06033
Pfizer Investigational Site
Glendale, Arizona, 85310
Pfizer Investigational Site
Glendale, California, 91206
Pfizer Investigational Site
Hartford, Connecticut, 06102
Pfizer Investigational Site
Hartford, Connecticut, 06106
Pfizer Investigational Site
Hollywood, Florida, 33021
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Jacksonville, Florida, 32250
Pfizer Investigational Site
Laguna Hills, California, 92653
Pfizer Investigational Site
Laguna Woods, California, 92653
Pfizer Investigational Site
Las Vegas, Nevada, 89106
Pfizer Investigational Site
Las Vegas, Nevada, 89117
Pfizer Investigational Site
Las Vegas, Nevada, 89121
Pfizer Investigational Site
Las Vegas, Nevada, 89144
Pfizer Investigational Site
Lexington, Kentucky, 40504
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Los Angeles, California, 90045
Pfizer Investigational Site
Morrow, Georgia, 30260
Pfizer Investigational Site
Northport, Alabama, 35476
Pfizer Investigational Site
Oak Park, Illinois, 60304
Pfizer Investigational Site
Orangeburg, South Carolina, 29110
Pfizer Investigational Site
Pheonix, Arizona, 85006
Pfizer Investigational Site
Pheonix, Arizona, 85008
Pfizer Investigational Site
Pheonix, Arizona, 85016
Pfizer Investigational Site
Phoenix, Arizona, 85016
Pfizer Investigational Site
Phoenix, Arizona, 85032
Pfizer Investigational Site
Plantation, Florida, 33324
Pfizer Investigational Site
Rocky Hill, Connecticut, 06067
Pfizer Investigational Site
Royal Oak, Michigan, 48073
Pfizer Investigational Site
Saint Augustine, Florida, 32086
Pfizer Investigational Site
San Antonio, Texas, 78127
Pfizer Investigational Site
San Antonio, Texas, 78209
Pfizer Investigational Site
San Antonio, Texas, 78217
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Antonio, Texas, 78240
Pfizer Investigational Site
San Marcos, Texas, 78666
Pfizer Investigational Site
Springfield, Missouri, 65804
Pfizer Investigational Site
Springfield, Missouri, 65807
Pfizer Investigational Site
St. Petersburg, Florida, 33703
Pfizer Investigational Site
Stockbridge, Georgia, 30281
Pfizer Investigational Site
Tempe, Arizona, 85281
Pfizer Investigational Site
Timonium, Maryland, 21093
Pfizer Investigational Site
Troy, Michigan, 48085
Pfizer Investigational Site
Weston, Florida, 33326
Pfizer Investigational Site
Windsor, Connecticut, 06095

Other trials in United States

Canada13 sites

Pfizer Investigational Site
Ajax, Ontario, L1S 2J4
Pfizer Investigational Site
Ajax, Ontario, L1S 2J5
Pfizer Investigational Site
Ajax, Ontario, L1S 7K8
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 1T2
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 3C8
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 4V5
Pfizer Investigational Site
Kingston, Ontario, K7L 2V7
Pfizer Investigational Site
Kingston, Ontario, K7L 5G2
Pfizer Investigational Site
Scarborough Village, Ontario, M1E 4B9
Pfizer Investigational Site
Toronto, Ontario, M3M 2C2
Pfizer Investigational Site
Toronto, Ontario, M5T 2S8
Pfizer Investigational Site
Vancouver, British Columbia, V6Z 1Y6
Pfizer Investigational Site
Weston, Ontario, M9N 1N8

Other trials in Canada

About this study

Official title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg QD And Valdecoxib 20 Mg BID Compared To Placebo Over Multiple Days For Management Of Acute Postsurgical Pain In Patients Undergoing Anterior Cruciate Ligament Reconstruction

The primary objective was to evaluate the analgesic efficacy of valdecoxib 20 mg daily and valdecoxib 20 mg twice daily compared with placebo in outpatients with moderate-severe pain after arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. Secondary objectives were to compare each valdecoxib dose with placebo on additional measures of pain intensity, health outcomes, the use of rescue medication, and the occurrence of opioid-related symptoms, and to evaluate their safety.

Conditions: Pain
Being tested: placebo, valdecoxib
Keywords: Post surgical pain, Anterior Cruciate ligament reconstruction, Arthroscopy, Perioperative pain
Medical subject headings: Pain, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

placeboDrug
valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, placebo BID by mouth on Days 2 to 5.
valdecoxibDrug
valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg once daily (QD) by mouth on Days 2 to 5.
valdecoxibDrug
valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg twice daily (BID) by mouth on Days 2 to 5.

Study groups in NCT00650039
Study group	Role	What they receive
Arm 1	Active comparator	Not described Receives: Drug: valdecoxib
Arm 2	Active comparator	Not described Receives: Drug: valdecoxib
Arm 3	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Summed Pain Intensity (categorical) through 24 hours (SPI 24)
Measured: Day 2 and Day 3
Patient's Global Evaluation of Study Medication (PGESM)
Measured: Day 2 and Day 3

Secondary outcomes (15)

Average Pain Intensity (derived from the mBPI-sf) on each study day
Measured: Days 2 to 5
Worst Pain Intensity (derived from the Modified Brief Pain Inventory Short Form [mBPI-sf]) on each study day
Measured: Days 2 to 5
Symptom Distress Scale Questionnaire
Measured: Days 2 to 5
Patient Satisfaction Questionnaire for each study day
Measured: Days 2 to 5
Time-specific pain intensity (PI) (categorical) on each study day
Measured: Days 2 to 5
SPI 24 (Visual Analog Scale [VAS]) on each study day
Measured: Days 2 to 5
Time-specific PI (VAS) on each study day
Measured: Days 2 to 5
Patient's Global Evaluation of Study Medication
Measured: Day 4 and Day 5
Time to first dose of rescue medication (supplemental analgesia) on each study day
Measured: Days 2 to 5
Percent of subjects who took rescue medication (supplemental analgesia) on each study day
Measured: Days 2 to 5
Amount of rescue medication (supplemental analgesia) taken on each study day
Measured: Days 2 to 5
Individual and Composite Pain Interference With Function score (derived from the mBPI-sf) on each day
Measured: Days 2 to 5
Time between doses of study medication on each study day
Measured: Days 2 to 5
Post-Discharge Recovery Experience for each study day
Measured: Days 2 to 5
SPI 24 (categorical)
Measured: Day 4 and Day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2004Feb 2005

First posted1 Apr 2008 (estimated)
Study startMar 2004
Study completionFeb 2005

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 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 488 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00650039
Sponsor's protocol ID: A3471109
Status last verified: Mar 2008
First submitted: 28 Mar 2008
Last updated: 4 Jun 2008
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg QD And Valdecoxib 20 Mg BID Compared To Placebo Over Multiple Days For Management Of Acute Postsurgical Pain In Patients Undergoing Anterior Cruciate Ligament Reconstruction
ClinicalTrials.gov ID: NCT00650039
Acronym / sponsor ID: A3471109
Conditions: Pain
Keywords: Post surgical pain, Anterior Cruciate ligament reconstruction, Arthroscopy, Perioperative pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 488 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Mar 2004
Study completion: Feb 2005 (actual)
First posted: 1 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Arm 1	Active comparator	Drug: valdecoxib
Arm 2	Active comparator	Drug: valdecoxib
Arm 3	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Included patients had uncomplicated arthroscopic ACL reconstruction
Subjects were to have a Baseline pain intensity of ≥ 50 mm as measured on a 0 - 100mm visual analogue scale (VAS) and moderate to severe pain on a categorical scale by 23:00 hours on the day of surgery and prior to being discharged from the surgical facility
Subjects could not have received any medication or additional procedures that would confound the interpretation of the study results.

Key exclusion criteria (7 listed)

the patient was admitted to or retained in the surgical center/hospital for >23 hours;
the patient underwent 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 used conventional nonsteroidal antiinflammatory drugs (NSAIDs), selective cyclooxygenase-2 (COX-2) inhibitors, or tramadol during the 6 hours preceding surgery, during surgery, or subsequent to the end of surgery;
the patient received oxaprozin or piroxicam within 1 week prior to randomization;
the patient had a pain pump or indwelling catheter during surgery that administered local or intraarticular anesthetics or narcotics at the index joint, or had such an intra-articular injection at the end of surgery;

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
placebovaldecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, placebo BID by mouth on Days 2 to 5.	Drug	Arm 3
valdecoxibvaldecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg once daily (QD) by mouth on Days 2 to 5.	Drug	Arm 2
valdecoxibvaldecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg twice daily (BID) by mouth on Days 2 to 5.	Drug	Arm 1

Primary outcome

Summed Pain Intensity (categorical) through 24 hours (SPI 24)
Time frame: Day 2 and Day 3
Patient's Global Evaluation of Study Medication (PGESM)
Time frame: Day 2 and Day 3

15 secondary outcomes

Average Pain Intensity (derived from the mBPI-sf) on each study day
Time frame: Days 2 to 5
Worst Pain Intensity (derived from the Modified Brief Pain Inventory Short Form [mBPI-sf]) on each study day
Time frame: Days 2 to 5
Symptom Distress Scale Questionnaire
Time frame: Days 2 to 5
Patient Satisfaction Questionnaire for each study day
Time frame: Days 2 to 5
Time-specific pain intensity (PI) (categorical) on each study day
Time frame: Days 2 to 5
SPI 24 (Visual Analog Scale [VAS]) on each study day
Time frame: Days 2 to 5
Time-specific PI (VAS) on each study day
Time frame: Days 2 to 5
Patient's Global Evaluation of Study Medication
Time frame: Day 4 and Day 5
Time to first dose of rescue medication (supplemental analgesia) on each study day
Time frame: Days 2 to 5
Percent of subjects who took rescue medication (supplemental analgesia) on each study day
Time frame: Days 2 to 5
Amount of rescue medication (supplemental analgesia) taken on each study day
Time frame: Days 2 to 5
Individual and Composite Pain Interference With Function score (derived from the mBPI-sf) on each day
Time frame: Days 2 to 5
Time between doses of study medication on each study day
Time frame: Days 2 to 5
Post-Discharge Recovery Experience for each study day
Time frame: Days 2 to 5
SPI 24 (categorical)
Time frame: Day 4 and Day 5

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 4 Jun 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

81 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing valdecoxib in people with Pain, run by Pfizer at 81 sites in 2 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 3 inclusion and 7 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 4 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Canada. 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 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?

Summed Pain Intensity (categorical) through 24 hours (SPI 24) (time frame: Day 2 and Day 3). 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?

On the ClinicalTrials.gov record for NCT00650039.

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 4 Jun 2008.