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Efficacy of XP20B Following Bunionectomy Surgery

This study has been completed.

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

U.S. FDA Resources

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

Further study details as provided by Xanodyne Pharmaceuticals:

Primary Outcome Measures:
  • Average pain over a fixed dosing period [ Time Frame: Multiple-day ]

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
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • having undergone bunionectomy surgery
  • having achieved the requisite level of pain

Exclusion Criteria:

  • pregnant or lactating
  • history of substance abuse
  • clinically significant condition or lab abnormality
  • taken any prohibited medications
  • gastrointestinal bleeding or history of
  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


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

Keywords provided by Xanodyne Pharmaceuticals:
pain  

Study placed in the following topic categories:
Pain

ClinicalTrials.gov processed this record on October 10, 2008

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