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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
Sponsor:
Information provided by:
POZEN

Brief 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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac
U.S. FDA Resources




Primary Outcome Measures :
  1. 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)
  2. To evaluate the safety and tolerability of lornoxicam administered to subjects with post-bunionectomy surgery pain.

Secondary Outcome Measures :
  1. To determine the time to onset of analgesic effect and peak analgesic effect of lornoxicam (8 mg and 16 mg) compared to placebo.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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


Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Sponsors and Collaborators
POZEN
Investigators
Principal Investigator: Michael P. DeMicco, MD Advanced Clinical Research Institute

ClinicalTrials.gov Identifier: NCT00293631     History of Changes
Other Study ID Numbers: LNP-202
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: December 3, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Lornoxicam
Piroxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action