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Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00293631
First Posted: February 17, 2006
Last Update Posted: December 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
POZEN
  Purpose
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 Intervention Phase
Bunionectomy Orthopedic Surgery Drug: Lornoxicam 8 mg Drug: Lornoxicam 16 mg Drug: Ketorolac 30 mg Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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).

Resource links provided by NLM:


Further study details as provided by POZEN:

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

Estimated Enrollment: 100
Study Start Date: November 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00293631     History of Changes
Other Study ID Numbers: LNP-202
First Submitted: February 15, 2006
First Posted: February 17, 2006
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