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Opioid Analgesic
A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
Phase 3
Waitlist Available
Research Sponsored by Talphera, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial
Summary
The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.
Eligible Conditions
- Postoperative Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patient Global Satisfaction
Side effects data
From 2013 Phase 3 trial • 419 Patients • NCT0166076335%
Nausea
11%
Vomiting
7%
Oxygen Saturation Decreased
5%
Dizziness
5%
Pruritus
5%
Constipation
4%
Insomnia
4%
Headache
4%
Hypotension
3%
Confusional State
1%
Pyrexia
1%
Dry Mouth
1%
Orthostatic Hypotension
1%
Sedation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sufentanil NanoTab PCA System/15 mcg
Placebo Sufentanil NanoTab PCA System
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sufentanil NanoTab PCA System/15 mcgExperimental Treatment1 Intervention
Group II: morphine IV PCAActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sufentanil
FDA approved
Find a Location
Who is running the clinical trial?
Talphera, IncLead Sponsor
17 Previous Clinical Trials
1,965 Total Patients Enrolled
AcelRx Pharmaceuticals, Inc.Lead Sponsor
16 Previous Clinical Trials
1,799 Total Patients Enrolled
Pamela Palmer, M.D., PhDStudy DirectorTalphera, Inc
4 Previous Clinical Trials
792 Total Patients Enrolled