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Showing 1–22 of 22 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: sublingual sufentanil Clear all
Completed Phase 2 Interventional Results available

A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Elective Unilateral Total Knee Replacement

NCT00612534
View directory record Official record
Conditions
Post Operative Pain
Interventions
Sufentanil NanoTab, Placebo NanoTab
Drug
Lead sponsor
Talphera, Inc
Industry
Eligibility
45 Years to 80 Years
Enrollment
94 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Feb 16, 2014 · Synced Sep 5, 2026, 3:23 AM EDT
Not listed No phase listed Observational

DSUVIA in Patients With SCD VOC Present in the ED

NCT05388188
View directory record Official record
Conditions
Sickle-Cell Disease With Crisis
Interventions
sublingual sufentanil
Drug
Lead sponsor
Jason Wilson
Other
Eligibility
18 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
Tampa, Florida
Source: ClinicalTrials.gov public record
Updated May 23, 2022 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 3 Interventional Results available

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery

NCT01539642
View directory record Official record
Conditions
Post-Operative Pain
Interventions
Sufentanil NanoTab PCA System/15 mcg, Placebo Sufentanil NanoTab PCA System
Drug
Lead sponsor
Talphera, Inc
Industry
Eligibility
18 Years and older
Enrollment
172 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
12
States / cities
Mobile, Alabama • Laguna Hills, California • Stamford, Connecticut + 9 more
Source: ClinicalTrials.gov public record
Updated Oct 19, 2015 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Effect of Delivery Route on PK of Sufentanil NanoTab

NCT01639729
View directory record Official record
Conditions
Pharmacokinetics
Interventions
Treatment A: Sufentanil IV, Treatment B: Sufentanil NanoTab Sublingual, Treatment C: Sufentanil NanoTab Buccal, Treatment D: Sufentanil NanoTab Oral
Drug
Lead sponsor
Talphera, Inc
Industry
Eligibility
18 Years to 45 Years
Enrollment
25 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012
U.S. locations
1
States / cities
Lenexa, Kansas
Source: ClinicalTrials.gov public record
Updated Sep 30, 2015 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects

NCT02082236
View directory record Official record
Conditions
Healthy
Interventions
Treatment Arm A: Sufenta®, Treatment B: Sufentanil SSM 30 mcg, Treatment C: SSM 15 mcg, Treatment D: SSM 30 mcg
Drug
Lead sponsor
Talphera, Inc
Industry
Eligibility
18 Years to 45 Years
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Lenexa, Kansas
Source: ClinicalTrials.gov public record
Updated Jul 16, 2018 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 3 Interventional Results available

Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg

NCT02662764
View directory record Official record
Conditions
Moderate-to-severe Acute Pain
Interventions
Zalviso™ 15 mcg
Drug
Lead sponsor
Talphera, Inc
Industry
Eligibility
18 Years and older
Enrollment
320 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
11
States / cities
Florence, Alabama • Sheffield, Alabama • Phoenix, Arizona + 6 more
Source: ClinicalTrials.gov public record
Updated Aug 7, 2018 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 4 Interventional Results available

Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center

NCT04387136
View directory record Official record
Conditions
Pain, Pain, Acute, Anesthesia
Interventions
Sublingual Sufentanil
Drug
Lead sponsor
University of Minnesota
Other
Eligibility
18 Years to 80 Years
Enrollment
53 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
1
States / cities
Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Jun 27, 2022 · Synced Sep 5, 2026, 3:23 AM EDT
Not listed Phase 4 Interventional

Improving Pain Management and Decreasing LOS After Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA)

NCT05307341
View directory record Official record
Conditions
Pain
Interventions
sufentanil
Drug
Lead sponsor
More Foundation
Other
Eligibility
50 Years to 80 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
Phoenix, Arizona
Source: ClinicalTrials.gov public record
Updated Mar 31, 2022 · Synced Sep 5, 2026, 3:23 AM EDT
Terminated Phase 4 Interventional Results available

Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery

NCT04561375
View directory record Official record
Conditions
Knee Arthroscopy
Interventions
Sufentanil, Fentanyl
Drug
Lead sponsor
The Cleveland Clinic
Other
Eligibility
18 Years and older
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Dec 12, 2023 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 4 Interventional Results available

The Impact of Sublingual Sufentanil on Postoperative Pain and Analgesic Requirements in Spine Surgery Patients

NCT04263909
View directory record Official record
Conditions
Spine Fusion, Pain, Postoperative, Opioid Use
Interventions
Sublingual Tablet
Drug
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
18 Years to 85 Years
Enrollment
199 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Mar 29, 2025 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

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

NCT00718081
View directory record Official record
Conditions
Major Upper or Lower Abdominal Surgery
Interventions
Oral sufentanil, Placebo
Drug
Lead sponsor
Talphera, Inc
Industry
Eligibility
18 Years to 80 Years
Enrollment
88 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008 – 2009
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Jan 21, 2015 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 3 Interventional Results available

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
View directory record Official record
Conditions
Acute Moderate-to-severe Pain
Interventions
sufentanil sublingual tablet 30 mcg
Drug
Lead sponsor
Talphera, Inc
Industry
Eligibility
40 Years and older
Enrollment
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016
U.S. locations
2
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Mar 14, 2017 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 1Phase 2 Interventional Accepts healthy volunteers Results available

Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Sufentanil

NCT04959812
View directory record Official record
Conditions
Healthy
Interventions
Sufentanil, Placebo
Drug · Other
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years to 45 Years
Enrollment
46 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2023
U.S. locations
2
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Jun 25, 2025 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

NCT01761565
View directory record Official record
Conditions
Plasma Concentrations
Interventions
Single dose of SUF NT 15 mcg, 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Drug
Lead sponsor
Talphera, Inc
Industry
Eligibility
18 Years to 45 Years
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013
U.S. locations
1
States / cities
Lenexa, Kansas
Source: ClinicalTrials.gov public record
Updated Sep 30, 2015 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 4 Interventional Results available

Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center

NCT04177862
View directory record Official record
Conditions
Pain, Pain, Acute, Anesthesia
Interventions
Sublingual Sufentanil, IV Fentanyl
Drug
Lead sponsor
University of Minnesota
Other
Eligibility
18 Years to 80 Years
Enrollment
75 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Apr 18, 2021 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 3 Interventional Results available

DSUVIA Early Evaluation of Pain Trial

NCT05288348
View directory record Official record
Conditions
Traumatic Injury
Interventions
Sufentanil 30 MCG Sublingual Tablet, standard care pain treatment
Drug
Lead sponsor
Frank Guyette
Other
Eligibility
18 Years to 70 Years
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Apr 29, 2025 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 3 Interventional Results available

Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain

NCT02447848
View directory record Official record
Conditions
Moderate-to-severe Acute Pain
Interventions
sufentanil sublingual 30 mcg tablet
Drug
Lead sponsor
Talphera, Inc
Industry
Eligibility
18 Years and older
Enrollment
76 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
3
States / cities
Minneapolis, Minnesota • Houston, Texas
Source: ClinicalTrials.gov public record
Updated Oct 18, 2017 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 2 Interventional Results available

A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction Procedure

NCT00894699
View directory record Official record
Conditions
Sedation, Anxiety, Pain
Interventions
Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03), Placebo NanoTab™
Drug
Lead sponsor
Talphera, Inc
Industry
Eligibility
18 Years to 60 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009
U.S. locations
1
States / cities
Pasadena, California
Source: ClinicalTrials.gov public record
Updated Jun 24, 2014 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 2 Interventional Results available

A Study for the Evaluation of the Safety, Tolerability, and Efficacy of ARX-F02 (Sufentanil NanoTab) Compared to Placebo in the Treatment of Cancer Breakthrough Pain

NCT00833040
View directory record Official record
Conditions
Cancer, Pain
Interventions
Sublingual sufentanil NanoTabs™ and placebo NanoTabs™
Drug
Lead sponsor
Talphera, Inc
Industry
Eligibility
18 Years and older
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
13
States / cities
Montebello, California • Jacksonville, Florida • Lakeland, Florida + 10 more
Source: ClinicalTrials.gov public record
Updated Dec 31, 2014 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 3 Interventional Results available

A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery

NCT02356588
View directory record Official record
Conditions
Post-Operative Pain
Interventions
Sufentanil Tablet 30 mcg, Placebo Tablet
Drug
Lead sponsor
Talphera, Inc
Industry
Eligibility
18 Years and older
Enrollment
161 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015
U.S. locations
4
States / cities
Sheffield, Alabama • Pasadena, California • Houston, Texas
Source: ClinicalTrials.gov public record
Updated Feb 12, 2017 · Synced Sep 5, 2026, 3:23 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 mcg (Zalviso™) for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery

NCT01660763
View directory record Official record
Conditions
Post Operative Pain
Interventions
Sufentanil NanoTab PCA System/15 mcg, Placebo Sufentanil NanoTab PCA System
Drug
Lead sponsor
Talphera, Inc
Industry
Eligibility
18 Years and older
Enrollment
419 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
1
States / cities
Damascus, Maryland
Source: ClinicalTrials.gov public record
Updated Oct 19, 2015 · Synced Sep 5, 2026, 3:23 AM EDT
Terminated Phase 4 Interventional Results available

Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment

NCT04716413
View directory record Official record
Conditions
Acute Pain
Interventions
Dsuvia
Drug
Lead sponsor
Montefiore Medical Center
Other
Eligibility
18 Years to 100 Years
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
1
States / cities
The Bronx, New York
Source: ClinicalTrials.gov public record
Updated Jul 18, 2023 · Synced Sep 5, 2026, 3:23 AM EDT