NCT00293631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2006

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

Enrollment Period

4 months

First QC Date

February 15, 2006

Last Update Submit

November 29, 2012

Conditions

BunionectomyOrthopedic Surgery

Outcome Measures

Primary Outcomes (2)

  • 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 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.

Interventions

Lornoxicam 8 mgDRUG
Lornoxicam 16 mgDRUG
Ketorolac 30 mgDRUG
PlaceboDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

MeSH Terms

Interventions

lornoxicamKetorolac

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Michael P. DeMicco, MD

    Advanced Clinical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 15, 2006

First Posted

February 17, 2006

Study Start

November 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

December 3, 2012

Record last verified: 2012-11

Locations

US(1)