CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Sufentanil NanoTab PCA System/15 mcgdrug
Likely dose
Sufentanil NanoTab PCA System/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/NCT00859313
NCT00859313Phase 2Completed
CompareCT.gov

An Open-Label Functionality, Safety, and Efficacy Study of the NanoTab® Delivery System/ARX-F01 15 Mcg in Patients Undergoing Elective Unilateral Knee Replacement

Talphera, Inc·interventional·Posted Mar 11, 2009·Updated Mar 1, 2012

In Brief

A Phase 2 clinical trial evaluating Sufentanil NanoTab PCA System/15 mcg for Pain, Postoperative. Completed, enrolled 30 participants across 3 sites.

Detailed Summary

This study is being performed to evaluate the functionality of a device (Sufentanil NanoTab® PCA System) that has been developed for use by patients to self-administer the ARX-F01 pain medication (Sufentanil NanoTab 15 mcg) for the treatment of post-operative pain after undergoing knee replacement surgery. Another goal of this study is to assess the safety and effectiveness of this non-invasive, sublingual route of administration of ARX-F01 in decreasing the amount of pain that a patient experiences following knee replacement surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2009
Enrollment StartApr 1, 2009
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.3 years ago

Interventions

Sufentanil NanoTab PCA System/15 mcgdrug

15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours