- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00293631
Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy
November 29, 2012 updated by: POZEN
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Anaheim, California, United States, 92801
- Advanced Clinical Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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)
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To evaluate the safety and tolerability of lornoxicam administered to subjects with post-bunionectomy surgery pain.
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Secondary Outcome Measures
Outcome Measure |
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael P. DeMicco, MD, Advanced Clinical Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
March 1, 2006
Study Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
February 15, 2006
First Submitted That Met QC Criteria
February 15, 2006
First Posted (Estimate)
February 17, 2006
Study Record Updates
Last Update Posted (Estimate)
December 3, 2012
Last Update Submitted That Met QC Criteria
November 29, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ketorolac
- Piroxicam
- Lornoxicam
Other Study ID Numbers
- LNP-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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