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OpenTrials
Completed

NCT Number: NCT00655291

Efficacy of XP20B 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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigatve Site, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XP20B

Drug

Placebo

Drug

Primary outcomes

  1. Average pain over a fixed dosing period

    Time frame: Multiple-day

Secondary outcomes

  1. multiple pain assessments over a fixed dosing period

    Time frame: Multiple-day

  2. Rescue medication use

    Time frame: Multiple-day

  3. Safety evaluations

    Time frame: Multiple-day

Sponsors and collaborators

Lead sponsor

Xanodyne Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 9, 2008
Registry last updated
Oct 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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