Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery
NCT00683137
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 450 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | February 2003 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00683137 | |||
Other Study ID Numbers ICMJE | VALA-0513-144 A3471084 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | May 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |