PainPhase 3NCT00683137

Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery

A Phase 3 study testing valdecoxib in people with Pain and Hallux Valgus, run by Pfizer at 89 sites in United States.

Completed

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

Trial summary

The study was done to evaluate the pain relief and safety of 2 valdecoxib doses compared to placebo in patients with moderate or severe pain following bunionectomy surgery, and to evaluate the effect of the 2 valdecoxib doses compared to placebo on health outcome measures and on the occurrence of opioid related… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Hallux Valgus
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: 450 participants
Where: 89 sitesUnited States
Study dates: Oct 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) who required open manipulation of bone with periosteal evaluation under general anesthesia (Mayo block)
Patients with a baseline pain intensity (VAS) of greater than or equal to 45 mm
Patients with a baseline pain intensity (categorical) of moderate or severe

Who cannot join

Patients scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
Treatment with patient-controlled analgesia (PCA) subsequent to the end of anesthesia
Long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
Use of tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, COX-2 inhibitors, NSAIDs, and corticosteroids
Use of NSAID or analgesia after midnight the night prior to surgery or unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study

Trial locations and contacts

89 sites in 1 country.

City, postcode or hospital

89 sites in 1 country

United States89 sites

Pfizer Investigational Site
Addison, Illinois, 60101
Pfizer Investigational Site
Altoona, Pennsylvania, 16602
Pfizer Investigational Site
Altoona, Pennsylvania
Pfizer Investigational Site
Annapolis, Maryland, 21401
Pfizer Investigational Site
Austin, Texas, 78731
Pfizer Investigational Site
Austin, Texas, 78756
Pfizer Investigational Site
Austintown, Ohio, 44515
Pfizer Investigational Site
Bismarck, North Dakota, 58501
Pfizer Investigational Site
Canfield, Ohio, 44406
Pfizer Investigational Site
Chandler, Arizona, 85224
Pfizer Investigational Site
Chester, Maryland, 21619
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Cooper City, Florida, 33330
Pfizer Investigational Site
Cutler Ridge, Florida, 33157
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
Elk Grove Village, Illinois, 60007
Pfizer Investigational Site
Evansville, Indiana, 47713
Pfizer Investigational Site
Fort Lauderdale, Florida, 33306
Pfizer Investigational Site
Fort Lauderdale, Florida, 33308
Pfizer Investigational Site
Glendale, Arizona, 85302
Pfizer Investigational Site
Glendale, Arizona, 85306
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Hallandale, Florida, 33009
Pfizer Investigational Site
Havertown, Pennsylvania, 19083
Pfizer Investigational Site
Holladay, Utah, 84117
Pfizer Investigational Site
Hollywood, Florida, 33020
Pfizer Investigational Site
Hollywood, Florida, 33021
Pfizer Investigational Site
Las Vegas, Nevada, 89102
Pfizer Investigational Site
Las Vegas, Nevada, 89104
Pfizer Investigational Site
Las Vegas, Nevada, 89106
Pfizer Investigational Site
Las Vegas, Nevada, 89121
Pfizer Investigational Site
Las Vegas, Nevada, 89128
Pfizer Investigational Site
Layton, Utah, 84041
Pfizer Investigational Site
Media, Pennsylvania, 19063
Pfizer Investigational Site
Mesa, Arizona, 85204
Pfizer Investigational Site
Miami, Florida, 33180
Pfizer Investigational Site
Milford, Connecticut, 06460
Pfizer Investigational Site
National City, California, 91950
Pfizer Investigational Site
New Haven, Connecticut, 06515
Pfizer Investigational Site
New Haven, Connecticut, 6515
Pfizer Investigational Site
New Orleans, Louisiana, 70127
Pfizer Investigational Site
New Orleans, Louisiana, 70128
Pfizer Investigational Site
New Port Richey, Florida, 34652
Pfizer Investigational Site
New Port Richey, Florida, 34653
Pfizer Investigational Site
New Port Richey, Florida, 34655
Pfizer Investigational Site
Omaha, Nebraska, 68124
Pfizer Investigational Site
Omaha, Nebraska, 68134
Pfizer Investigational Site
Omaha, Nebraska, 68144
Pfizer Investigational Site
Pembroke Pines, Florida, 33027
Pfizer Investigational Site
Pembroke Pines, Florida, 33028
Pfizer Investigational Site
Peoria, Illinois, 61602
Pfizer Investigational Site
Peoria, Illinois, 61614
Pfizer Investigational Site
Peoria, Illinois, 61615
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107-2496
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19140
Pfizer Investigational Site
Philadelphia, Pennsylvania
Pfizer Investigational Site
Phoenix, Arizona, 58029
Pfizer Investigational Site
Phoenix, Arizona, 85012
Pfizer Investigational Site
Phoenix, Arizona, 85015
Pfizer Investigational Site
Phoenix, Arizona, 85016
Pfizer Investigational Site
Phoenix, Arizona, 85022
Pfizer Investigational Site
Phoenix, Arizona, 85023
Pfizer Investigational Site
Port Richey, Florida, 34668
Pfizer Investigational Site
Portland, Oregon, 97205
Pfizer Investigational Site
Provo, Utah, 84054
Pfizer Investigational Site
Reading, Pennsylvania, 19606
Pfizer Investigational Site
Salt Lake City, Utah, 84102
Pfizer Investigational Site
Salt Lake City, Utah, 84107
Pfizer Investigational Site
Salt Lake City, Utah, 84117
Pfizer Investigational Site
Salt Lake City, Utah, 84124
Pfizer Investigational Site
Salt Lake City, Utah, 84157-0667
Pfizer Investigational Site
San Antonio, Texas, 78205
Pfizer Investigational Site
San Antonio, Texas, 78209
Pfizer Investigational Site
San Antonio, Texas, 78240
Pfizer Investigational Site
San Antonio, Texas
Pfizer Investigational Site
San Diego, California, 91950
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Diego, California, 92114
Pfizer Investigational Site
San Diego, California, 92116
Pfizer Investigational Site
Sandy City, Utah, 84070
Pfizer Investigational Site
South Miami, Florida, 33143
Pfizer Investigational Site
Spring Hill, Florida, 34608
Pfizer Investigational Site
St. George, Utah, 84770
Pfizer Investigational Site
State College, Pennsylvania, 16803
Pfizer Investigational Site
Tacoma, Washington, 98431-5000
Pfizer Investigational Site
Upland, Pennsylvania, 19013
Pfizer Investigational Site
Wyomissig, Pennsylvania, 19610
Pfizer Investigational Site
Youngstown, Ohio, 44512
Pfizer Investigational Site
Youngstown, Ohio, 44515

Other trials in United States

About this study

Official title: Clinical Protocol for a Multiple Dose Randomized, Double-Blind, Placebo Controlled Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Placebo in Patients for Treatment of Post-Surgical Pain From Bunionectomy Surgery

Conditions: Pain, Hallux Valgus
Being tested: valdecoxib, valdecoxib/placebo
Medical subject headings: Pain, Hallux Valgus

What participants receive

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

valdecoxibDrug
valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth once daily on Days 2 through 5
valdecoxibDrug
valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth twice daily on Days 2 through 5
valdecoxib/placeboDrug
valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then placebo on Days 2 through 5

Study groups in NCT00683137
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	Active comparator	Not described Receives: Drug: valdecoxib/placebo

What is being measured

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

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

Secondary outcomes (15)

Health Outcomes Post-Discharge Recovery Experience
Measured: Days 2 to 5
adverse events
Measured: continuous
Time to first dose of rescue medication (rescue analgesic medication)
Measured: Days 2 to 5
SPI 24 (categorical)
Measured: Day 4 and Day 5
Time-specific Pain Intensity (PI) (categorical)
Measured: Days 2 to 5
SPI 24 (Visual Analog Scale [VAS])
Measured: Days 2 to 5
Time-specific PI (VAS)
Measured: Days 2 to 5
Patient's Global Evaluation of Study Medication
Measured: Day 4 and Day 5
Percent of patients who took rescue medication (rescue analgesic medication)
Measured: Days 2 to 5
Worst Pain Intensity (derived from the Modified BPI-Short Form)
Measured: Days 2 to 5
Time between doses of study medication
Measured: Days 2 to 5
Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form)
Measured: Days 2 to 5
Symptom Distress Questionnaire
Measured: Days 2 to 5
Average Pain Intensity (derived from the Modified BPI-Short Form)
Measured: Days 2 to 5
Amount of rescue medication (rescue analgesic medication) taken
Measured: Days 2 to 5

Timeline

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

Oct 2002Feb 2003

First posted23 May 2008 (estimated)
Study startOct 2002
Study completionFeb 2003

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00683137
Sponsor's protocol ID: VALA-0513-144
Other IDs: A3471084
Status last verified: May 2008
First submitted: 31 Mar 2008
Last updated: 23 May 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 23 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Protocol for a Multiple Dose Randomized, Double-Blind, Placebo Controlled Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Placebo in Patients for Treatment of Post-Surgical Pain From Bunionectomy Surgery
ClinicalTrials.gov ID: NCT00683137
Acronym / sponsor ID: VALA-0513-144
Conditions: Pain, Hallux Valgus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2002
Study completion: Feb 2003 (actual)
First posted: 23 May 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: Double blind (participant, investigator)
Number of arms: 3

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

Who may qualify

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

Key inclusion criteria (3 listed)

Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) who required open manipulation of bone with periosteal evaluation under general anesthesia (Mayo block)
Patients with a baseline pain intensity (VAS) of greater than or equal to 45 mm
Patients with a baseline pain intensity (categorical) of moderate or severe

Key exclusion criteria (5 listed)

Patients scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
Treatment with patient-controlled analgesia (PCA) subsequent to the end of anesthesia
Long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
Use of tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, COX-2 inhibitors, NSAIDs, and corticosteroids
Use of NSAID or analgesia after midnight the night prior to surgery or unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during 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 tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth once daily on Days 2 through 5	Drug	Arm 1
valdecoxibvaldecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth twice daily on Days 2 through 5	Drug	Arm 2
valdecoxib/placebovaldecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then placebo on Days 2 through 5	Drug	Arm 3

Primary outcome

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

15 secondary outcomes

Health Outcomes Post-Discharge Recovery Experience
Time frame: Days 2 to 5
adverse events
Time frame: continuous
Time to first dose of rescue medication (rescue analgesic medication)
Time frame: Days 2 to 5
SPI 24 (categorical)
Time frame: Day 4 and Day 5
Time-specific Pain Intensity (PI) (categorical)
Time frame: Days 2 to 5
SPI 24 (Visual Analog Scale [VAS])
Time frame: Days 2 to 5
Time-specific PI (VAS)
Time frame: Days 2 to 5
Patient's Global Evaluation of Study Medication
Time frame: Day 4 and Day 5
Percent of patients who took rescue medication (rescue analgesic medication)
Time frame: Days 2 to 5
Worst Pain Intensity (derived from the Modified BPI-Short Form)
Time frame: Days 2 to 5
Time between doses of study medication
Time frame: Days 2 to 5
Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form)
Time frame: Days 2 to 5
Symptom Distress Questionnaire
Time frame: Days 2 to 5
Average Pain Intensity (derived from the Modified BPI-Short Form)
Time frame: Days 2 to 5
Amount of rescue medication (rescue analgesic medication) taken
Time frame: Days 2 to 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 23 May 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

89 sites in 1 country: 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 and Hallux Valgus, run by Pfizer at 89 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 3 inclusion and 5 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 23 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 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. 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?

Patient's Global Evaluation of Study Medication (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 NCT00683137.

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 23 May 2008.