Efficacy of XP20B Following Bunionectomy Surgery

Acute Pain Clinical Trial

Official title:

Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study of the Analgesic Efficacy of XP20B in Subjects With Pain Following Bunionectomy Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655291
• Other study ID #: XP20B-301
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2008
• Last updated: October 7, 2008
• Start date: April 2008
• Est. completion date: August 2008

Study information

• Verified date: October 2008
• Source: Xanodyne Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• XP20B

• Placebo

Locations

Country	Name	City	State
United States	Investigatve Site	Anaheim	California
United States	Investigative Site	Austin	Texas
United States	Investigative Site	Houston	Texas
United States	Investigative Site	Owings Mills	Maryland
United States	Investigative Site	Salt Lake City	Utah
United States	Investigative Site	San Marcos	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Xanodyne Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average pain over a fixed dosing period		Multiple-day
Secondary	multiple pain assessments over a fixed dosing period		Multiple-day
Secondary	Rescue medication use		Multiple-day
Secondary	Safety evaluations		Multiple-day