Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy
Information source: Pozen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bunionectomy; Orthopedic Surgery
Intervention: Lornoxicam 8 mg (Drug); Lornoxicam 16 mg (Drug); Ketorolac 30 mg (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Pozen Official(s) and/or principal investigator(s):
Michael P. DeMicco, MD, Principal Investigator, Affiliation: Advanced Clinical Research Institute
Summary
To determine whether a single dose of intravenous lornoxicam is superior to intravenous
placebo for management of post-operative pain in patients who have surgical removal of a
bunion on the lower extremity. One-fourth of patients in this study will receive a single
dose of intravenous ketorolac for management of pain and one-fourth of patients in this study
will receive a single dose of an intravenous placebo.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: To determine the time to onset of analgesic effect and peak analgesic effect of lornoxicam (8 mg and 16 mg) compared to placebo.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects who are scheduled for a primary unilateral first metatarsal bunionectomy
under local anesthetic.
- Subjects have no contraindications to this surgery and have no allergies to the study
medications or similar medications.
- Subjects are in generally good health with no uncontrolled chronic illnesses or
diseases.
Exclusion Criteria:
- Subjects who are pregnant.
- Subjects who have significant obesity.
- Subjects with medically significant heart, liver, kidney, lung or endocrine disease.
- Subjects with active viral disease, i. e. hepatitis, HIV.
Locations and Contacts
Advanced Clinical Research Institute, Anaheim, California 92801, United States
Additional Information
Starting date: November 2005
Last updated: March 29, 2006
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