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Completed

NCT Number: NCT01710345

Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy

This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lotus Clinical Research, Pasadena, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients scheduled for bunion surgery

Exclusion criteria

  • daily opioid use
  • drug or alcohol abuse
  • pregnant or breastfeeding women

Treatment and study plan

Sufentanil NanoTab 20 mcg

Drug

Sufentanil NanoTab 30 mcg

Drug

Placebo NanoTab

Drug

Primary outcomes

  1. SPID-12

    Time frame: 12 hours

    The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point.

    The SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better.

Sponsors and collaborators

Lead sponsor

Talphera, Inc

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 19, 2012
Registry last updated
Jan 26, 2015

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

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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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