Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:

Drug Information available for: Valdecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Total Pain Relief through 24 hours (TOTPAR 24) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Patient's Global Evaluation of Study Medication [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

time between doses of study medication [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Time-specific Pain Intensity Difference (PID) (categorical) [ Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours ] [ Designated as safety issue: No ]
time-specific pain relief [ Time Frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours ] [ Designated as safety issue: No ]
time-specific PID (VAS) [ Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours ] [ Designated as safety issue: No ]
Summed Pain Intensity (SPID)24 (VAS) [ Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours ] [ Designated as safety issue: No ]
time to rescue medication [ Time Frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours ] [ Designated as safety issue: No ]
percent of patients who took rescue medication [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Patient's Satisfaction Questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]


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)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site


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
Health Authority:	United States: Food and Drug Administration

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 September 30, 2016