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

Sponsored by:	Pozen
Information provided by:	Pozen
ClinicalTrials.gov Identifier:	NCT00293631

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 II

Drug Information available for: Ketorolac Ketorolac tromethamine Lornoxicam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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).

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	LNP-202
Study First Received:	February 15, 2006
Last Updated:	March 29, 2006
ClinicalTrials.gov Identifier:	NCT00293631
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lornoxicam
Signs and Symptoms
Postoperative Complications
Ketorolac

Pain
Ketorolac Tromethamine
Pain, Postoperative

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Pathologic Processes
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009