Efficacy of XP20B Following Bunionectomy Surgery

This study has been completed.

First Received: April 3, 2008 Last Updated: October 7, 2008 History of Changes

Sponsored by:	Xanodyne Pharmaceuticals
Information provided by:	Xanodyne Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00655291

Purpose

The purpose of this study is to determine if XP20B is an effective treatment for the relief of pain following bunionectomy surgery.

Condition	Intervention	Phase
Acute Pain	Drug: XP20B Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study of the Analgesic Efficacy of XP20B in Subjects With Pain Following Bunionectomy Surgery

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Further study details as provided by Xanodyne Pharmaceuticals:

Primary Outcome Measures:

Secondary Outcome Measures:

multiple pain assessments over a fixed dosing period [ Time Frame: Multiple-day ]
Rescue medication use [ Time Frame: Multiple-day ]
Safety evaluations [ Time Frame: Multiple-day ]

Estimated Enrollment:	190
Study Start Date:	April 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator	Drug: Placebo
B: Experimental	Drug: XP20B

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655291

Locations

United States, California
Investigatve Site
Anaheim, California, United States, 92810
United States, Maryland
Investigative Site
Owings Mills, Maryland, United States, 21117
United States, Texas
Investigative Site
Austin, Texas, United States, 78705
Investigative Site
Houston, Texas, United States, 78705
Investigative Site
San Marcos, Texas, United States, 78666
United States, Utah
Investigative Site
Salt Lake City, Utah, United States, 84117

Sponsors and Collaborators

Xanodyne Pharmaceuticals

Investigators

Investigator:

Keith Moore, PharmD

Xanodyne Pharmaceuticals

More Information

No publications provided

Responsible Party:	Xanodyne Pharmaceuticals ( Caroline Masoner/Clinical Trial Manager )
Study ID Numbers:	XP20B-301
Study First Received:	April 3, 2008
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00655291 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Xanodyne Pharmaceuticals:

pain

Study placed in the following topic categories:

Pain
Analgesics

ClinicalTrials.gov processed this record on September 09, 2009