CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03) +1 moredrug
Likely dose
Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03) 15 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00894699
NCT00894699Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTabs™ in Patients Undergoing an Elective Abdominal Liposuction Procedure

Talphera, Inc·interventional·Posted May 7, 2009·Updated Jun 25, 2014

In Brief

A Phase 2 clinical trial evaluating Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03) and Placebo NanoTab™ for Sedation and 2 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety and effectiveness of a study medication that contains a combination of a pain medication, sufentanil, and a sedative, triazolam. This drug is being designed to provide mild sedation as well as reduce anxiety and pain before and during a procedure (in this case elective abdominal liposuction).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSedation, Anxiety, Pain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2009
Enrollment StartJun 1, 2009
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 17.2 years ago

Interventions

Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03)drug

Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™

Placebo NanoTab™drug

Single dose of sublingual placebo NanoTab™