Efficacy of XP20B Following Bunionectomy Surgery
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
XP20B
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring pain
Eligibility 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
Sites / Locations
- Investigatve Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Average pain over a fixed dosing period
Secondary Outcome Measures
multiple pain assessments over a fixed dosing period
Rescue medication use
Safety evaluations
Full Information
NCT ID
NCT00655291
First Posted
April 3, 2008
Last Updated
October 7, 2008
Sponsor
Xanodyne Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00655291
Brief Title
Efficacy of XP20B Following Bunionectomy Surgery
Official Title
Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study of the Analgesic Efficacy of XP20B in Subjects With Pain Following Bunionectomy Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Xanodyne Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if XP20B is an effective treatment for the relief of pain following bunionectomy surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
XP20B
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Average pain over a fixed dosing period
Time Frame
Multiple-day
Secondary Outcome Measure Information:
Title
multiple pain assessments over a fixed dosing period
Time Frame
Multiple-day
Title
Rescue medication use
Time Frame
Multiple-day
Title
Safety evaluations
Time Frame
Multiple-day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Moore, PharmD
Organizational Affiliation
Xanodyne Pharmaceuticals
Facility Information:
Facility Name
Investigatve Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92810
Country
United States
Facility Name
Investigative Site
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Investigative Site
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of XP20B Following Bunionectomy Surgery
We'll reach out to this number within 24 hrs