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

NCT01710345 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2015-01-26

Study results available
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Summary

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.

Conditions

  • Acute Pain

Interventions

DRUG

Sufentanil NanoTab 20 mcg

DRUG

Sufentanil NanoTab 30 mcg

DRUG

Placebo NanoTab

Sponsors & Collaborators

  • Talphera, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01710345 on ClinicalTrials.gov