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Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00653354
First received: April 1, 2008
Last updated: April 7, 2008
Last verified: April 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Pain, Post-Surgical | Drug: valdecoxib Drug: valdecoxib/placebo Drug: placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 360 |
| Study Start Date: | December 2002 |
| Study Completion Date: | March 2003 |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Arm 1 |
Drug: valdecoxib
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
|
| Active Comparator: Arm 2 |
Drug: valdecoxib/placebo
valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
|
| Placebo Comparator: Arm 3 |
Drug: placebo
placebo within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00653354
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653354
Locations
| United States, Arizona | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85015 | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85016 | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85020 | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85032 | |
| Pfizer Investigational Site | |
| Tempe, Arizona, United States, 85281 | |
| United States, California | |
| Pfizer Investigational Site | |
| Anaheim, California, United States, 92701 | |
| Pfizer Investigational Site | |
| Chula Vista, California, United States, 91911 | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92114 | |
| Pfizer Investigational Site | |
| Santa Ana, California, United States, 92701 | |
| Pfizer Investigational Site | |
| Tustin, California, United States, 92780 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States, 40504 | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States, 40509 | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States, 40515 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Altoona, Pennsylvania, United States, 16602 | |
| Pfizer Investigational Site | |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Johnson City,, Tennessee, United States, 37601 | |
| Pfizer Investigational Site | |
| Johnson City, Tennessee, United States, 37601 | |
| Pfizer Investigational Site | |
| Johnson City, Tennessee, United States, 37604 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78240 | |
| United States, Utah | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84117 | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84123 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00653354 History of Changes |
| Other Study ID Numbers: |
VALA-0513-149 A3471086 |
| Study First Received: | April 1, 2008 |
| Last Updated: | April 7, 2008 |
Keywords provided by Pfizer:
|
hallux valgus |
Additional relevant MeSH terms:
|
Analgesics Valdecoxib Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on July 27, 2017