Efficacy of XP20B Following Bunionectomy Surgery

Xanodyne Pharmaceuticals190 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

190

Conditions

Acute Pain

Interventions

XP20BDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

Investigatve Site

Anaheim, California, United States

Investigative Site

Owings Mills, Maryland, United States

Investigative Site

Austin, Texas, United States

Investigative Site

Houston, Texas, United States

Outcomes

Primary Outcomes

Average pain over a fixed dosing period

Time frame: Multiple-day

Secondary Outcomes

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

Data from ClinicalTrials.gov

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