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

POZEN

Status and phase

Completed

Phase 2

Conditions

Orthopedic Surgery

Bunionectomy

Treatments

Drug: Lornoxicam 8 mg

Drug: Lornoxicam 16 mg

Drug: Ketorolac 30 mg

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00293631

LNP-202

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.