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

Tracking Information

First Received Date ^ICMJE

February 15, 2006

Last Updated Date

March 29, 2006

Start Date ^ICMJE

November 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00293631 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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).

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bunionectomy
Orthopedic Surgery

Intervention ^ICMJE

Drug: Lornoxicam 8 mg
Drug: Lornoxicam 16 mg
Drug: Ketorolac 30 mg
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00293631

Responsible Party

Study ID Numbers ^ICMJE

LNP-202

Study Sponsor ^ICMJE

Pozen

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Michael P. DeMicco, MD

Advanced Clinical Research Institute

Information Provided By

Pozen

Verification Date

March 2006

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