Clinical trials: Sufentanil
Moderate-to-severe Acute Pain
Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg
Study to evaluate the overall performance of the Zalviso System™ (sufentanil sublingual tablet system) 15 mcg
- Trial name
- NCT02662764
- Testing
- Zalviso™ 15 mcg
- Where
- 11 sites in United States
- Volunteers
- 320 people
- Sponsor
- Talphera, Inc
Post-Operative Pain
A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery
The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of moderate-to-severe acute post-operative pain…
- Trial name
- NCT02356588
- Testing
- Sufentanil Tablet 30 mcg
- Where
- 4 sites in United States
- Volunteers
- 161 people
- Sponsor
- Talphera, Inc
Acute Pain
Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy
This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain.
- Trial name
- NCT01710345
- Testing
- Sufentanil NanoTab 20 mcg, Sufentanil NanoTab 30 mcg
- Where
- 2 sites in United States
- Volunteers
- 101 people
- Sponsor
- Talphera, Inc
Moderate-to-severe Acute Pain
Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain
To evaluate the safety and efficacy of sufentanil tablet (ST) 30 mcg in the management of moderate-to-severe acute pain in patients in an emergency room (ER) setting.
- Trial name
- NCT02447848
- Testing
- sufentanil sublingual 30 mcg tablet
- Where
- 3 sites in United States
- Volunteers
- 76 people
- Sponsor
- Talphera, Inc
Cancer, Pain
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
The purpose of this research study was to evaluate ARX-F02 (Sufentanil NanoTab) versus placebo ("sugar" pill or inactive substance) in the management of breakthrough pain in cancer patients.
- Trial name
- NCT00833040
- Where
- 13 sites in United States
- Volunteers
- 34 people
- Sponsor
- Talphera, Inc
Post-Operative Pain
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
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.
- Trial name
- NCT01539538
- Testing
- Sufentanil NanoTab PCA System/15 mcg, morphine IV PCA
- Where
- 16 sites in United States
- Volunteers
- 357 people
- Sponsor
- Talphera, Inc
Major Upper or Lower Abdominal Surgery
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
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.
- Trial name
- NCT00718081
- Testing
- Oral sufentanil
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Talphera, Inc
Post Operative Pain
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
The purpose of this study is to evaluate three different dosage strengths of sublingual ARX-F01 (Sufentanil NanoTab) versus a sublingual Placebo NanoTab for the treatment of post-operative pain in subjects following total knee…
- Trial name
- ARX-F01 (NCT00612534)
- Testing
- Sufentanil NanoTab
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Talphera, Inc
Plasma Concentrations
Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab
Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs
- Trial name
- NCT01761565
- Testing
- Single dose of SUF NT 15 mcg, 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Talphera, Inc
Pain
Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients
The proposed study aims to investigate the safety, tolerability, analgesic efficacy, and feasibility of intranasal sufentanil/ketamine (CT001) in pediatric participants attending an acute care (i.e. emergency) setting.
- Trial name
- NCT06364072
- Testing
- CT001
- Where
- 7 sites in Spain, United Kingdom
- Volunteers
- 155 people
- Sponsor
- Cessatech A/S
Post-Operative Pain
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
The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after…
- Trial name
- NCT01539642
- Testing
- Sufentanil NanoTab PCA System/15 mcg
- Where
- 12 sites in United States
- Volunteers
- 172 people
- Sponsor
- Talphera, Inc
Post Operative Pain
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
The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after…
- Trial name
- NCT01660763
- Testing
- Sufentanil NanoTab PCA System/15 mcg
- Where
- United States
- Volunteers
- 419 people
- Sponsor
- Talphera, Inc
Acute Moderate-to-severe Pain
A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain
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…
- Trial name
- NCT02662556
- Testing
- sufentanil sublingual tablet 30 mcg
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- Talphera, Inc
Sedation, Anxiety
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
The purpose of this study is to evaluate the safety and effectiveness of a study medication that contains a combination of a pain medication, sufentanil, and a sedative, triazolam.
- Conditions
- Sedation, Anxiety, Pain
- Trial name
- NCT00894699
- Testing
- Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Talphera, Inc
Pharmacokinetics
Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics
Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.
- Trial name
- NCT01721070
- Testing
- Sufentanil NanoTab (SUF NT) 15 mcg, Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Talphera, Inc
Pharmacokinetics
Effect of Delivery Route on PK of Sufentanil NanoTab
Determine whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed.
- Trial name
- NCT01639729
- Testing
- Treatment A: Sufentanil IV, Treatment B: Sufentanil NanoTab Sublingual, Treatment C: Sufentanil NanoTab Buccal
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Talphera, Inc