Pain, Post-surgicalPhase 3NCT00653354
Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery
A Phase 3 study testing valdecoxib in people with Pain, Post-surgical, run by Pfizer at 21 sites in United States.
Trial summary
To assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib compared to placebo on the first post-operative day in patients with moderate or severe pain following bunionectomy surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Post-surgical
- 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
- 360 participants
- Where
- 21 sitesUnited States
- Study dates
- Dec 2002to Mar 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) requiring open manipulation of bone with periosteal elevation under regional anesthesia (Mayo block)
- Patients had a Baseline pain intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS
Who cannot join
- Patients who were scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
- Patients treated with patient controlled analgesia (PCA) subsequent to the end of anesthesia
- Patients treated with long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
- Patients expected to require analgesics or other agents other than study medication during the 8 hours preceding administration of study medication through the end of the treatment period, that could confound assessment of the analgesic response, specifically excluded were tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, cyclooxygenase-2 inhibitors, nonsteroidal antiinflammatory drugs, and corticosteroids
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Pfizer Investigational Site
Altoona, Pennsylvania, 16602
Pfizer Investigational Site
Anaheim, California, 92701
Pfizer Investigational Site
Chula Vista, California, 91911
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
Johnson City, Tennessee, 37601
Pfizer Investigational Site
Johnson City, Tennessee, 37604
Pfizer Investigational Site
Lexington, Kentucky, 40504
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Lexington, Kentucky, 40515
Pfizer Investigational Site
Phoenix, Arizona, 85015
Pfizer Investigational Site
Phoenix, Arizona, 85016
Pfizer Investigational Site
Phoenix, Arizona, 85020
Pfizer Investigational Site
Phoenix, Arizona, 85032
Pfizer Investigational Site
Salt Lake City, Utah, 84117
Pfizer Investigational Site
Salt Lake City, Utah, 84123
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Antonio, Texas, 78240
Pfizer Investigational Site
San Diego, California, 92114
Pfizer Investigational Site
Santa Ana, California, 92701
Pfizer Investigational Site
Tempe, Arizona, 85281
Pfizer Investigational Site
Tustin, California, 92780
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Assessment Of The Analgesic Efficacy Of The Dosing Regimen Of Valdecoxib Compared To Placebo Patients In Pain Following Bunionectomy
To assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib compared to placebo on the first post-operative day in patients with moderate or severe pain following bunionectomy surgery.
- Conditions
- Pain, Post-surgical
- Being tested
- valdecoxib, valdecoxib/placebo, placebo
- Keywords
- hallux valgus
- Medical subject headings
- Pain, Postoperative, 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 within 6 hours of surgery followed by valdecoxib 20 mg tablet by mouth 1 to 12 hours after the first dose
valdecoxib/placeboDrug
valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
placeboDrug
placebo within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: valdecoxib |
| Arm 2 | Active comparator | Not described Receives: Drug: valdecoxib/placebo |
| 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 Difference (categorical) through 24 hours (SPID 24)
Measured: Day 1
Total Pain Relief through 24 hours (TOTPAR 24)
Measured: Day 1
Patient's Global Evaluation of Study Medication
Measured: Day 1
Secondary outcomes (8)
time between doses of study medication
Measured: Day 1
Time-specific Pain Intensity Difference (PID) (categorical)
Measured: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
time-specific pain relief
Measured: 2, 4, 6, 8, 10, 12, 16, and 24 hours
time-specific PID (VAS)
Measured: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
Summed Pain Intensity (SPID)24 (VAS)
Measured: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
time to rescue medication
Measured: 2, 4, 6, 8, 10, 12, 16, and 24 hours
percent of patients who took rescue medication
Measured: Day 1
Patient's Satisfaction Questionnaire
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startDec 2002
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Post-surgicalStudies 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
- 360 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
- NCT00653354
- Sponsor's protocol ID
- VALA-0513-149
- Other IDs
- A3471086
- Status last verified
- Dec 2018
- First submitted
- 1 Apr 2008
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Assessment Of The Analgesic Efficacy Of The Dosing Regimen Of Valdecoxib Compared To Placebo Patients In Pain Following Bunionectomy
- ClinicalTrials.gov ID
- NCT00653354
- Acronym / sponsor ID
- VALA-0513-149
- Conditions
- Pain, Post-surgical
- Keywords
- hallux valgus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Study completion
- Mar 2003 (actual)
- First posted
- 4 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 assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib compared to placebo on the first post-operative day in patients with moderate or severe pain following bunionectomy surgery.
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/placebo |
| Arm 3 | Placebo comparator | Drug: placebo |
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 underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) requiring open manipulation of bone with periosteal elevation under regional anesthesia (Mayo block)
- Patients had a Baseline pain intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS
Key exclusion criteria (4 listed)
- Patients who were scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
- Patients treated with patient controlled analgesia (PCA) subsequent to the end of anesthesia
- Patients treated with long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
- Patients expected to require analgesics or other agents other than study medication during the 8 hours preceding administration of study medication through the end of the treatment period, that could confound assessment of the analgesic response, specifically excluded were tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, cyclooxygenase-2 inhibitors, nonsteroidal antiinflammatory drugs, and corticosteroids
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 within 6 hours of surgery followed by valdecoxib 20 mg tablet by mouth 1 to 12 hours after the first dose | Drug | Arm 1 |
| valdecoxib/placebovaldecoxib 40 mg tablet by mouth within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose | Drug | Arm 2 |
| placeboplacebo within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose | Drug | Arm 3 |
Primary outcome
Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24)
Time frame: Day 1
Total Pain Relief through 24 hours (TOTPAR 24)
Time frame: Day 1
Patient's Global Evaluation of Study Medication
Time frame: Day 1
8 secondary outcomes
time between doses of study medication
Time frame: Day 1
Time-specific Pain Intensity Difference (PID) (categorical)
Time frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
time-specific pain relief
Time frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours
time-specific PID (VAS)
Time frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
Summed Pain Intensity (SPID)24 (VAS)
Time frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
time to rescue medication
Time frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours
percent of patients who took rescue medication
Time frame: Day 1
Patient's Satisfaction Questionnaire
Time frame: Day 1
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 5 Dec 2018.
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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
21 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, Post-surgical, run by Pfizer at 21 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 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 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 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 Difference (categorical) through 24 hours (SPID 24) (time frame: Day 1). The study lists 3 primary outcomes in all. 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 5 Dec 2018.