Study of Lornoxicam or Ketorolac or Placebo for Post-Oper... | NCT00293631

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

NCT00293631

Sponsor

POZEN

Status

Completed

Last Update Posted

Dec 3, 2012Estimated

Enrollment

100

Phase

Phase 2

Conditions

Bunionectomy
Orthopedic Surgery

Interventions

Lornoxicam 8 mg
Lornoxicam 16 mg
Ketorolac 30 mg
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official 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).

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Nov 2005

Primary Completion Date

Mar 2006Actual

Completion Date

Mar 2006Actual

First Submitted Date

Feb 15, 2006

First Submission Date that Met QC Criteria

Feb 15, 2006

First Posted Date

Feb 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2012

Last Update Posted Date

Dec 3, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael P. DeMicco, MD	Advanced Clinical Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Advanced Clinical Research Institute		Anaheim	California	92801	United States

Intervention Browse Module

MeSH Terms

ID	Term
C059451	lornoxicam
D020910	Ketorolac

Ancestor Terms

ID	Term
D007213	Indomethacin
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Lornoxicam 8 mg	Drug
Lornoxicam 16 mg	Drug
Ketorolac 30 mg	Drug
Placebo	Drug