Efficacy of XP20B Following Bunionectomy Surgery

Phase 3

Completed

• Conditions: Acute Pain
• Interventions: Drug: Placebo; Drug: XP20B

• Registration Number: NCT00655291
• Lead Sponsor: Xanodyne Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-09
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-07
• Last Update Posted: 2008-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Placebo	-
B	XP20B	-

Primary Outcome Measures

Name	Time	Method
Average pain over a fixed dosing period	Multiple-day

Secondary Outcome Measures

Name	Time	Method
multiple pain assessments over a fixed dosing period	Multiple-day
Rescue medication use	Multiple-day
Safety evaluations	Multiple-day

Trial Locations

Locations (2)

Investigatve Site; 🇺🇸 Anaheim, California, United States

Investigative Site; 🇺🇸 Salt Lake City, Utah, United States