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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00293631
Other study ID # LNP-202
Secondary ID
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
Accepts healthy volunteers
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


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.
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