At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 320 enrolled
Drug / intervention
Zalviso™ 15 mcgdrug
Likely dose
Zalviso™ 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.
A Multicenter, Open-Label Trial to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg
In Brief
A Phase 3 clinical trial evaluating Zalviso™ 15 mcg for Moderate-to-severe Acute Pain. Completed, enrolled 320 participants across 11 sites.
Detailed Summary
Study to evaluate the overall performance of the Zalviso System™ (sufentanil sublingual tablet system) 15 mcg
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModerate-to-severe Acute Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartSep 2016
Primary CompletionApr 2017
Study CompletionMay 2017
TodayJul 2026
First PostedJan 26, 2016
Enrollment StartSep 28, 2016
Primary CompletionApr 14, 2017
Study CompletionMay 5, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.4 years ago
Interventions
Zalviso™ 15 mcgdrug
Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours