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

This study has been completed.
Sponsor:
Information provided by:
POZEN
ClinicalTrials.gov Identifier:
NCT00293631
First received: February 15, 2006
Last updated: November 29, 2012
Last verified: November 2012
History of Changes

February 15, 2006
November 29, 2012
November 2005
March 2006   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT00293631 on ClinicalTrials.gov Archive Site
To determine the time to onset of analgesic effect and peak analgesic effect of lornoxicam (8 mg and 16 mg) compared to placebo.
Same as current
Not Provided
Not Provided
 
Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy
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).

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Bunionectomy
  • Orthopedic Surgery
  • Drug: Lornoxicam 8 mg
  • Drug: Lornoxicam 16 mg
  • Drug: Ketorolac 30 mg
  • Drug: Placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2006
March 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00293631
LNP-202
Not Provided
Not Provided
POZEN
Not Provided
Principal Investigator: Michael P. DeMicco, MD Advanced Clinical Research Institute
POZEN
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP