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Efficacy of XP20B Following Bunionectomy Surgery

This study has been completed.
Sponsor:
Information provided by:
Xanodyne Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00655291
First received: April 3, 2008
Last updated: October 7, 2008
Last verified: October 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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
Placebo Comparator: A Drug: Placebo
Experimental: B 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Xanodyne Pharmaceuticals:
pain

Additional relevant MeSH terms:
Acute Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014