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

Condition(s) targeted: Pain; Hallux Valgus

Intervention: valdecoxib (Drug); valdecoxib (Drug); valdecoxib/placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

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

Primary outcome:

Patient's Global Evaluation of Study Medication

Summed Pain Intensity (SPI) (categorical) through 24 hours

Secondary outcome:

Health Outcomes Post-Discharge Recovery Experience

adverse events

Time to first dose of rescue medication (rescue analgesic medication)

SPI 24 (categorical)

Time-specific Pain Intensity (PI) (categorical)

SPI 24 (Visual Analog Scale [VAS])

Time-specific PI (VAS)

Patient's Global Evaluation of Study Medication

Percent of patients who took rescue medication (rescue analgesic medication)

Worst Pain Intensity (derived from the Modified BPI-Short Form)

Time between doses of study medication

Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form)

Symptom Distress Questionnaire

Average Pain Intensity (derived from the Modified BPI-Short Form)

Amount of rescue medication (rescue analgesic medication) taken

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Pfizer Investigational Site, Glendale, Arizona 85302, United States

Pfizer Investigational Site, Glendale, Arizona 85306, United States

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Pfizer Investigational Site, Phoenix, Arizona 85012, United States

Pfizer Investigational Site, Phoenix, Arizona 85015, United States

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Pfizer Investigational Site, Miami, Florida 33180, United States

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Pfizer Investigational Site, FORT LAUDERDALE, Florida 33308, United States

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Pfizer Investigational Site, Ft. Lauderdale, Florida 33306, United States

Pfizer Investigational Site, Ft. Lauderdale, Florida 33308, United States

Pfizer Investigational Site, Addison, Illinois 60101, United States

Pfizer Investigational Site, Elk Grove Village, Illinois 60007, United States

Pfizer Investigational Site, Peoria, Illinois 61602, United States

Pfizer Investigational Site, Peoria, Illinois 61614, United States

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Pfizer Investigational Site, Evansville, Indiana 47713, United States

Pfizer Investigational Site, New Orleans, Louisiana 70127, United States

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Pfizer Investigational Site, Annapolis, Maryland 21401, United States

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Pfizer Investigational Site, Omaha, Nebraska 68124, United States

Pfizer Investigational Site, Omaha, Nebraska 68134, United States

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Pfizer Investigational Site, Las Vegas, Nevada 89102, United States

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Pfizer Investigational Site, Las Vegas, Nevada 89121, United States

Pfizer Investigational Site, Las Vegas, Nevada 89128, United States

Pfizer Investigational Site, Bismarck, North Dakota 58501, United States

Pfizer Investigational Site, Cleveland, Ohio 44106, United States

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Pfizer Investigational Site, Canfield, Ohio 44406, United States

Pfizer Investigational Site, Youngstown, Ohio 44512, United States

Pfizer Investigational Site, Youngstown, Ohio 44515, United States

Pfizer Investigational Site, Portland, Oregon 97205, United States

Pfizer Investigational Site, Havertown, Pennsylvania 19083, United States

Pfizer Investigational Site, Media, Pennsylvania 19063, United States

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Pfizer Investigational Site, Upland, Pennsylvania 19013, United States

Pfizer Investigational Site, Wyomissig, Pennsylvania 19610, United States

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Pfizer Investigational Site, Duncansville, Pennsylvania 16635, United States

Pfizer Investigational Site, Altoona, Pennsylvania 16602, United States

Pfizer Investigational Site, State College, Pennsylvania 16803, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19107-2496, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19140, United States

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Pfizer Investigational Site, Greer, South Carolina 29651, United States

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Pfizer Investigational Site, Holladay, Utah 84117, United States

Pfizer Investigational Site, Layton, Utah 84041, United States

Pfizer Investigational Site, Provo, Utah 84054, United States

Pfizer Investigational Site, Salt Lake City, Utah 84102, United States

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Pfizer Investigational Site, Salt Lake City, Utah 84117, United States

Pfizer Investigational Site, Salt Lake City, Utah 84124, United States

Pfizer Investigational Site, Salt Lake City, Utah 84157-0667, United States

Pfizer Investigational Site, Sandy, Utah 84070, United States

Pfizer Investigational Site, St. George, Utah 84770, United States

Pfizer Investigational Site, Tacoma, Washington 98431-5000, United States

To obtain contact information for a study center near you, click here.

Starting date: October 2002
Ending date: February 2003
Last updated: May 22, 2008