At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Elective Unilateral Total Knee Replacement
In Brief
A Phase 2 clinical trial evaluating Sufentanil NanoTab and Placebo NanoTab for Post Operative Pain. Completed, enrolled 94 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
5 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
Placebo NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
10 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours