Efficacy of XP20B Following Bunionectomy Surgery

October 7, 2008 updated by: Xanodyne Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

190

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92810
        • Investigatve Site
    • Maryland
      • Owings Mills, Maryland, United States, 21117
        • Investigative Site
    • Texas
      • Austin, Texas, United States, 78705
        • Investigative Site
      • Houston, Texas, United States, 78705
        • Investigative Site
      • San Marcos, Texas, United States, 78666
        • Investigative Site
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B
Drug: XP20B
Placebo Comparator: A
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average pain over a fixed dosing period
Time Frame: Multiple-day
Multiple-day

Secondary Outcome Measures

Outcome Measure
Time Frame
multiple pain assessments over a fixed dosing period
Time Frame: Multiple-day
Multiple-day
Rescue medication use
Time Frame: Multiple-day
Multiple-day
Safety evaluations
Time Frame: Multiple-day
Multiple-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xanodyne Pharmaceuticals

Investigators

  • Keith Moore, PharmD, Xanodyne Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

April 3, 2008

First Submitted That Met QC Criteria

April 3, 2008

First Posted (Estimate)

April 9, 2008

Study Record Updates

Last Update Posted (Estimate)

October 8, 2008

Last Update Submitted That Met QC Criteria

October 7, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XP20B-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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