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

Orthopedic Surgery Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293631
• Other study ID #: LNP-202
• Status: Completed
• Phase: Phase 2
• First received: February 15, 2006
• Last updated: November 29, 2012
• Start date: November 2005
• Est. completion date: March 2006

Study information

• Verified date: November 2012
• Source: POZEN
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bunionectomy
• Orthopedic Surgery

Intervention

Drug:
• Lornoxicam 8 mg

• Lornoxicam 16 mg

• Ketorolac 30 mg

• Placebo

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
POZEN

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	To evaluate the safety and tolerability of lornoxicam administered to subjects with post-bunionectomy surgery pain.
Secondary	To determine the time to onset of analgesic effect and peak analgesic effect of lornoxicam (8 mg and 16 mg) compared to placebo.