NCT00655291

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

October 8, 2008

Status Verified

October 1, 2008

Enrollment Period

4 months

First QC Date

April 3, 2008

Last Update Submit

October 7, 2008

Conditions

Acute Pain

Keywords

pain

Outcome Measures

Primary Outcomes (1)

  • Average pain over a fixed dosing period

    Multiple-day

Secondary Outcomes (3)

  • multiple pain assessments over a fixed dosing period

    Multiple-day

  • Rescue medication use

    Multiple-day

  • Safety evaluations

    Multiple-day

Study Arms (2)

A

PLACEBO COMPARATOR
Drug: Placebo

B

EXPERIMENTAL
Drug: XP20B

Interventions

XP20BDRUG
B
PlaceboDRUG
A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • having undergone bunionectomy surgery
  • having achieved the requisite level of pain

You may not qualify if:

  • pregnant or lactating
  • history of substance abuse
  • clinically significant condition or lab abnormality
  • taken any prohibited medications
  • gastrointestinal bleeding or history of

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Investigatve Site

Anaheim, California, 92810, United States

Location

Investigative Site

Owings Mills, Maryland, 21117, United States

Location

Investigative Site

Austin, Texas, 78705, United States

Location

Investigative Site

Houston, Texas, 78705, United States

Location

Investigative Site

San Marcos, Texas, 78666, United States

Location

Investigative Site

Salt Lake City, Utah, 84117, United States

Location

MeSH Terms

Conditions

Acute PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Keith Moore, PharmD

    Xanodyne Pharmaceuticals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 3, 2008

First Posted

April 9, 2008

Study Start

April 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

October 8, 2008

Record last verified: 2008-10

Locations

US(6)