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

Phase 2

Completed

• Conditions: Bunionectomy; Orthopedic Surgery

• Registration Number: NCT00293631
• Lead Sponsor: POZEN

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

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-02-15
• Study First Submitted QC: 2006-02-15
• Study First Posted: 2006-02-17
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-29
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Advanced Clinical Research Institute; 🇺🇸 Anaheim, California, United States