Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy
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|ClinicalTrials.gov Identifier: NCT00293631|
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : December 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bunionectomy Orthopedic Surgery||Drug: Lornoxicam 8 mg Drug: Lornoxicam 16 mg Drug: Ketorolac 30 mg Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Parallel-Group, Double-Blind, Single-Dose Study Evaluating the Efficacy and Safety of Intravenous Lornoxicam (8 mg and 16 mg) Compared to Intravenous Placebo and Ketorolac 30 mg in Management of Acute Postoperative Pain Following Orthopedic Surgery (Bunionectomy).|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
- The analgesic efficacy (TOTPAR) over 0-12 hours measured on a 100 point Visual Analog Scale (VAS) of a single intravenous dose of lornoxicam (8 mg or 16 mg) compared to placebo in the treatment of post-orthopedic surgery (bunionectomy)
- To evaluate the safety and tolerability of lornoxicam administered to subjects with post-bunionectomy surgery pain.
- To determine the time to onset of analgesic effect and peak analgesic effect of lornoxicam (8 mg and 16 mg) compared to placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293631
|United States, California|
|Advanced Clinical Research Institute|
|Anaheim, California, United States, 92801|
|Principal Investigator:||Michael P. DeMicco, MD||Advanced Clinical Research Institute|