Efficacy of XP20B Following Bunionectomy Surgery

Xanodyne Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Acute Pain

Treatments: Drug: XP20B; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00655291

XP20B-301

Details and patient eligibility

About

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

Enrollment: 190 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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190 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Treatment:

Drug: Placebo

B

Experimental group

Treatment:

Drug: XP20B