A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain
Recruiting at 1 trial location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Talphera, Inc
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure. Patients may receive one dose of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.
Research Team
PP
Pamela P. Palmer, MD, PhD
Principal Investigator
Talphera, Inc
Eligibility Criteria
Inclusion Criteria
Male or female patients who are 40 years of age or older.
Patients who have undergone a surgical procedure with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation.
Patients classified as American Society of Anesthesiologists (ASA) class IIII (Appendix I).
Treatment Details
Interventions
- Sufentanil Sublingual Tablet 30 mcg (Opioid Analgesic)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: sufentanil sublingual tablet 30 mcgExperimental Treatment1 Intervention
sufentanil sublingual tablet 30 mcg
Find a Clinic Near You
Who Is Running the Clinical Trial?
Talphera, Inc
Lead Sponsor
Trials
18
Recruited
2,300+
AcelRx Pharmaceuticals, Inc.
Lead Sponsor
Trials
17
Recruited
2,200+