Conditions: Post Operative Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 94
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate three different dosage strengths of sublingual ARX-F01 (Sufentanil NanoTab) versus a sublingual Placebo NanoTab for the treatment of post-operative pain in subjects following total knee replacement surgery. We hypothesize that subjects receiving placebo will have poor pain relief and will drop out of the study sooner and more often than the ARX-F01-treated subjects.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Sufentanil NanoTab intervention 2: Placebo NanoTab intervention 3: Sufentanil NanoTab intervention 4: Sufentanil NanoTab
Intervention descriptions: intervention 1: 5 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours intervention 2: Placebo NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours intervention 3: 10 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours intervention 4: 15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours

Protocol document: