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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00653354

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 III

MedlinePlus related topics: Surgery

Drug Information available for: Valdecoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy 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

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
Arm 1: Active Comparator	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
Arm 2: Active Comparator	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
Arm 3: Placebo Comparator	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
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

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, 85020
Pfizer Investigational Site
Phoenix, Arizona, United States, 85032
Pfizer Investigational Site
Phoenix, Arizona, United States, 85016
Pfizer Investigational Site
Tempe, Arizona, United States, 85281
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92701
Pfizer Investigational Site
Santa Ana, California, United States, 92701
Pfizer Investigational Site
Tustin, California, United States, 92780
Pfizer Investigational Site
Chula Vista, California, United States, 91911
Pfizer Investigational Site
San Diego, California, United States, 92114
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, 37604
Pfizer Investigational Site
Johnson City,, Tennessee, United States, 37601
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

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

Link to ClinicalStudyResults.org posting: This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	VALA-0513-149, A3471086
Study First Received:	April 1, 2008
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00653354
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

hallux valgus

Study placed in the following topic categories:

Hallux Valgus
Pain
Valdecoxib

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 06, 2009