Efficacy of XP20B Following Bunionectomy Surgery

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00655291

Enrollment

190

Registered

2008-04-09

Start date

2008-04-30

Completion date

2008-08-31

Last updated

2008-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Keywords

pain

Brief summary

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

Interventions

DRUGXP20B

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Average pain over a fixed dosing period	Multiple-day

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026