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

Acute Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01710345
• Other study ID #: SAP202
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2012
• Last updated: January 23, 2015
• Start date: October 2012
• Est. completion date: February 2013

Study information

• Verified date: January 2015
• Source: AcelRx Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients scheduled for bunion surgery

Exclusion Criteria:

• daily opioid use

• drug or alcohol abuse

• pregnant or breastfeeding women

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Sufentanil NanoTab 20 mcg

• Sufentanil NanoTab 30 mcg

• Placebo NanoTab

Locations

Country	Name	City	State
United States	Lotus Clinical Research	Pasadena	California
United States	Jean Brown Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
AcelRx Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SPID-12	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.	12 hours	No