MedDataX Logo

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

NCT ID: NCT00293631

Last Updated: 2012-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bunionectomy Orthopedic Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lornoxicam 8 mg

Intervention Type DRUG

Lornoxicam 16 mg

Intervention Type DRUG

Ketorolac 30 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

POZEN

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael P. DeMicco, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Clinical Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Advanced Clinical Research Institute

Anaheim, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LNP-202

Identifier Type: -

Identifier Source: org_study_id