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Completed

NCT Number: NCT00293631

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

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Key information

Conditions

Bunionectomy Orthopedic Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lornoxicam 8 mg

Drug

Lornoxicam 16 mg

Drug

Ketorolac 30 mg

Drug

Placebo

Drug

Primary outcomes

  1. 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)

  2. To evaluate the safety and tolerability of lornoxicam administered to subjects with post-bunionectomy surgery pain.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

POZEN

Industry

Registry information

Official study 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).

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Feb 17, 2006
Registry last updated
Dec 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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