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A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain

NCT02662556 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2017-03-15

Study results available
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Summary

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.

Conditions

  • Acute Moderate-to-severe Pain

Interventions

DRUG

sufentanil sublingual tablet 30 mcg

sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Sponsors & Collaborators

  • Talphera, Inc

    lead INDUSTRY

Principal Investigators

  • Pamela P. Palmer, MD, PhD · Talphera, Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-06-30
Completion
2016-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02662556 on ClinicalTrials.gov