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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00683137

Purpose

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 symptoms.

Condition	Intervention	Phase
Pain Hallux Valgus	Drug: valdecoxib Drug: valdecoxib/placebo	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Valdecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Patient's Global Evaluation of Study Medication [ Time Frame: Day 2 and Day 3 ] [ Designated as safety issue: No ]
Summed Pain Intensity (SPI) (categorical) through 24 hours [ Time Frame: Day 2 and Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Health Outcomes Post-Discharge Recovery Experience [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
adverse events [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
Time to first dose of rescue medication (rescue analgesic medication) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
SPI 24 (categorical) [ Time Frame: Day 4 and Day 5 ] [ Designated as safety issue: No ]
Time-specific Pain Intensity (PI) (categorical) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
SPI 24 (Visual Analog Scale [VAS]) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Time-specific PI (VAS) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Patient's Global Evaluation of Study Medication [ Time Frame: Day 4 and Day 5 ] [ Designated as safety issue: No ]
Percent of patients who took rescue medication (rescue analgesic medication) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Worst Pain Intensity (derived from the Modified BPI-Short Form) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Time between doses of study medication [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Symptom Distress Questionnaire [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Average Pain Intensity (derived from the Modified BPI-Short Form) [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]
Amount of rescue medication (rescue analgesic medication) taken [ Time Frame: Days 2 to 5 ] [ Designated as safety issue: No ]

Enrollment:	450
Study Start Date:	October 2002
Study Completion Date:	February 2003

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: valdecoxib 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
Arm 2: Active Comparator	Drug: valdecoxib 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
Arm 3: Active Comparator	Drug: valdecoxib/placebo 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

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) 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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683137

Show 91 Study Locations

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

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	VALA-0513-144, A3471084
Study First Received:	March 31, 2008
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00683137 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hallux Valgus
Anti-Inflammatory Agents
Cyclooxygenase Inhibitors
Pain
Musculoskeletal Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal

Analgesics
Peripheral Nervous System Agents
Congenital Abnormalities
Valdecoxib
Antirheumatic Agents
Foot Deformities

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Hallux Valgus
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Musculoskeletal Diseases
Sensory System Agents

Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Valdecoxib
Foot Deformities
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009