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

Talphera

Status and phase: Completed; Phase 2

Conditions: Acute Pain

Treatments: Drug: Placebo NanoTab; Drug: Sufentanil NanoTab 30 mcg; Drug: Sufentanil NanoTab 20 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01710345

SAP202

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients scheduled for bunion surgery

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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101 participants in 3 patient groups, including a placebo group

Sufentanil NanoTab 20 mcg

Experimental group

Description:

Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours

Treatment:

Drug: Sufentanil NanoTab 20 mcg

Sufentanil NanoTab 30 mcg

Experimental group

Description:

Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours

Treatment:

Drug: Sufentanil NanoTab 30 mcg

Placebo NanoTab

Placebo Comparator group

Description:

Placebo NanoTab as needed every 60 minutes for 12 hours

Treatment:

Drug: Placebo NanoTab