At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 88 enrolled
Drug / intervention
Oral sufentanil +1 moredrug
Likely dose
Not stated in 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, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Major Abdominal Surgery
In Brief
A Phase 2 clinical trial evaluating Oral sufentanil and Placebo for Major Upper or Lower Abdominal Surgery. Completed, enrolled 88 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate dosages of ARX-F01 (opioid pain medication) versus a placebo (or sugar pill) for the treatment of post-operative pain in subjects following abdominal 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
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Upper or Lower Abdominal Surgery
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2008
Enrollment StartAug 2008
Primary CompletionMar 2009
TodayJul 2026
First PostedJul 18, 2008
Enrollment StartAug 1, 2008
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.0 years ago
Interventions
Oral sufentanildrug
Oral dosage of sufentanil
Placebodrug
Oral dosage of placebo