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Talphera, Inc.

TLPH
Healthcare|Drug Manufacturers - Specialty & Generic|US
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Clinical Trials (18)

TrialConditionsPhaseStatusEnrollmentDesignDrug
NCT02447848
Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain
Moderate-to-severe Acute Pain
P3
Completed76Open-labelsufentanil sublingual 30 mcg tablet
NCT01539642
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
Post-Operative Pain
P3
Completed172RCT, Double-blindSufentanil NanoTab PCA System/15 mcg, Placebo Sufentanil NanoTab PCA System
NCT01539538
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
Post-Operative Pain
P3
Completed357RCT, Open-labelSufentanil NanoTab PCA System/15 mcg, morphine IV PCA
NCT01660763
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
Post Operative Pain
P3
Completed419RCT, Double-blindSufentanil NanoTab PCA System/15 mcg, Placebo Sufentanil NanoTab PCA System
NCT02356588
A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery
Post-Operative Pain
P3
Completed161RCT, Double-blindSufentanil Tablet 30 mcg, Placebo Tablet
NCT02662556
A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain
Acute Moderate-to-severe Pain
P3
Completed140Open-labelsufentanil sublingual tablet 30 mcg
NCT02662764
Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg
Moderate-to-severe Acute Pain
P3
Completed320Open-labelZalviso™ 15 mcg
NCT01710345
Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy
Acute Pain
P2
Completed101RCT, Double-blindSufentanil NanoTab 20 mcg, Sufentanil NanoTab 30 mcg, Placebo NanoTab
NCT00859313
An Open-Label Functionality, Safety and Efficacy Study in Patients Undergoing Elective Unilateral Knee Replacement
Pain, Postoperative
P2
Completed30Open-labelSufentanil NanoTab PCA System/15 mcg
NCT00894699
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
Sedation, Anxiety
P2
Completed40RCT, Double-blindSublingual Sufentanil/Triazolam NanoTab™ (ARX-F03), Placebo NanoTab™
NCT00833040
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
Cancer, Pain
P2
Completed34RCT, Double-blindSublingual sufentanil NanoTabs™ and placebo NanoTabs™
NCT00718081
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
Major Upper or Lower Abdominal Surgery
P2
Completed88RCT, Double-blindOral sufentanil, Placebo
NCT00612534
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
Post Operative Pain
P2
Completed94RCT, Double-blindSufentanil NanoTab, Placebo NanoTab, Sufentanil NanoTab, Sufentanil NanoTab
NCT01721070
Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics
Pharmacokinetics
P1
Completed19Open-labelSufentanil NanoTab (SUF NT) 15 mcg, Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg
NCT01761565
Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab
Plasma Concentrations
P1
Completed40Open-labelSingle dose of SUF NT 15 mcg, 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
NCT01639729
Effect of Delivery Route on PK of Sufentanil NanoTab
Pharmacokinetics
P1
Completed25RCT, Open-labelTreatment A: Sufentanil IV, Treatment B: Sufentanil NanoTab Sublingual, Treatment C: Sufentanil NanoTab Buccal, Treatment D: Sufentanil NanoTab Oral
NCT02082236
Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects
Healthy
P1
Completed40RCT, Open-labelTreatment Arm A: Sufenta®, Treatment B: Sufentanil SSM 30 mcg, Treatment C: SSM 15 mcg, Treatment D: SSM 30 mcg
NCT06150742
Nafamostat Efficacy in Phase 3 Registrational CRRT Study
Acute Kidney Injury
N/A
Unknown70RCT, Double-blind—