Clinical trials: Dexmedetomidine
Obstructive Sleep Apnea (OSA)
Correlation Endoscopic View of Airway Obstruction With RRa in OSA Patients Under DEX Monitored With SedLine EEG
Patients with obstructive sleep apnea (OSA) could have several anatomical causes of obstruction. A sleep endoscopy study is a technique to help determine the anatomical cause of OSA.
- Trial name
- NCT02639884
- Testing
- SedLine EEG, RRa monitoring
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Masimo Corporation
Intubated and Mechanically Ventilated Pediatric Subjects
Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects
The objective of this study is to characterize the pharmacokinetic and pharmacodynamic profile of dexmedetomidine administered as an intravenous loading dose followed by a continuous intravenous infusion in pediatric subjects…
- Trial name
- NCT00652028
- Testing
- Dexmedetomidine, midazolam; fentanyl
- Where
- 9 sites in United States, Guatemala
- Volunteers
- 69 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Pain, Post-operative
Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy
The primary objective of this study is to evaluate the analgesic efficacy of two dose levels of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute…
- Trial name
- NCT02169336
- Testing
- Intranasal Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 95 people
- Sponsor
- Baudax Bio
ICU Sedation
Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit
To evaluate the efficacy, safety, and pharmacokinetics of dexmedetomidine given as continuous IV infusion in pediatric subjects [≥ 45 weeks CGA (corrected gestational age) to <17 years old] requiring sedation under intensive care…
- Trial name
- NCT02757625
- Testing
- Dexmedetomidine hydrochloride
- Where
- 12 sites in Japan
- Volunteers
- 63 people
- Sponsor
- Pfizer
Agitation, Delirium
Study of BXCL501 In Agitation Associated With Delirium in ICU Patients
This study is designed to determine and evaluate the optimal BXCL501 starting dose (StartD) that will safely and effectively reduce agitation associated with delirium in ICU patients.
- Trial name
- NCT05313386
- Testing
- BXCL501
- Where
- United States
- Sponsor
- BioXcel Therapeutics Inc
Delirium
A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Hip Fracture Repair Surgery
The purpose of this study is to evaluate the efficacy and safety of perioperative use of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing surgery for fractured hip with general anesthesia.
- Trial name
- NCT00460473
- Testing
- Dexmedetomidine
- Where
- 30 sites in United States
- Volunteers
- 52 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Pain, Postoperative
Dexmedetomidine Transdermal System (DMTS) for Post-Operative Analgesia Following Bunionectomy
The purpose of this study is to evaluate whether the DMTS, compared with a placebo patch, will provide adequate pain relief during the first 3 days following bunionectomy surgery.
- Trial name
- DMTS (NCT02953054)
- Testing
- DMTS
- Where
- 2 sites in Australia
- Volunteers
- 88 people
- Sponsor
- Teikoku Pharma USA, Inc.
Agitation,Psychomotor, Dementia
Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia
This is an adaptive Phase 1b/2 trial design. It is randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL-501 dosing in adult (65 years…
- Trial name
- TRANQUILITY (NCT04251910)
- Testing
- Sublingual film containing Dexmedetomidine
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- BioXcel Therapeutics Inc
Alzheimer Disease
Pharmacological Enhancement of Glymphatic Function in Humans
Alzheimer's disease is linked in part to the buildup of harmful proteins in the brain, including amyloid and tau. Most current treatments aim to remove these proteins directly.
- Trial name
- NCT07432997
- Testing
- Dexmedetomidine, Dexmedetomidine and Midodrine
- Where
- 2 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Applied Cognition
Agitation, Schizophrenia
Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia
This is a two-stage adaptive Phase Ib trial design, that will identify two doses (lowest dose with clinical benefit and highest safe dose) in a first stage and better evaluate safety, tolerability and variability of effect in the…
- Trial name
- NCT04010305
- Testing
- Sublingual film containing BXCL501 (Dexmedetomidine)
- Where
- 12 sites in United States
- Volunteers
- 135 people
- Sponsor
- BioXcel Therapeutics Inc
Continuous Sedation in Initially Sedated Adults in ICU
Dexmedetomidine Versus Midazolam for Continuous Sedation in the Intensive Care Unit (ICU)
Patients in ICU who need help with their breathing are put onto a machine called a ventilator and are also given a medicine, called a sedative, which helps them to sleep and makes them more comfortable.
- Trial name
- MIDEX (NCT00481312)
- Testing
- Dexmedetomidine, Midazolam
- Where
- 43 sites in Belgium, Estonia and 7 more
- Volunteers
- 501 people
- Sponsor
- Orion Corporation, Orion Pharma
Sedation, Pain
Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months
The purpose of this study is to investigate the pharmacokinetic, pharmacodynamic, and safety of dexmedetomidine at 2 different dose levels in pediatric subjects, aged 12 months through <24 months, administered as an intravenous…
- Trial name
- NCT01378988
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Sedation
Precedex Special Investigation (in Pediatric Patients)
Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.
- Trial name
- NCT04040439
- Testing
- Dexmedetomidine Hydrochloride
- Where
- Japan
- Volunteers
- 111 people
- Sponsor
- Pfizer
Schizophrenia, Schizo-Affective Disorder
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
- Conditions
- Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I
- Trial name
- NCT05025605
- Testing
- BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
- Where
- 5 sites in United States
- Volunteers
- 140 people
- Sponsor
- BioXcel Therapeutics Inc
Continuous Sedation in Initially Sedated Adults in ICU
Dexmedetomidine Versus Propofol for Continuous Sedation in the Intensive Care Unit (ICU)
Patients in the ICU who need help with their breathing are put onto a machine called a ventilator and are also given a medicine, called a sedative, which helps them to sleep and makes them more comfortable.
- Trial name
- Prodex (NCT00479661)
- Testing
- Dexmedetomidine, Propofol
- Where
- 40 sites in Belgium, Finland and 5 more
- Volunteers
- 500 people
- Sponsor
- Orion Corporation, Orion Pharma
Preoperative Sedation
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Adults
The study is being conducted to evaluate the efficacy and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in adults.
- Trial name
- NCT04383418
- Testing
- dexmedetomidine hydrochloride nasal spray, dexmedetomidine hydrochloride nasal spray blank preparation
- Where
- China
- Volunteers
- 309 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Pain, Postoperative
Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty
The primary objective of this study is to evaluate the analgesic efficacy of DMTS, compared with placebo, in subjects following abdominoplasty.
- Trial name
- DMT2111 (NCT05412992)
- Testing
- DMTS Patch
- Where
- 2 sites in United States
- Volunteers
- 179 people
- Sponsor
- Teikoku Pharma USA, Inc.
Anesthesia
Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age
The primary objective of this study is to characterize the safety, and efficacy of Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a continuous IV infusion in preterm subjects, ages ≥ 28 weeks…
- Trial name
- NCT01508455
- Testing
- Dexmedetomidine, Midazolam, Fentanyl
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Healthy Subjects
A Repeat Dose Study of the Dexmedetomidine Transdermal System in Healthy Subjects
This Phase 1, 16-day Repeat dose study will evaluate the safety of a Dexmedetomidine Transdermal System (DMTS) skin system in healthy adults Subjects.
- Trial name
- NCT07818330
- Testing
- Dexmedetomidine Transdermal System (DMTS)
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Teikoku Pharma USA, Inc.
Sedation
A Study to Learn About the Study Medicine - Precedex in Children From Japan.
The purpose of this study is to look at the safety of Precedex when it was used to calm children at procedures or tests under actual medical practice in Japan.
- Trial name
- NCT06085573
- Testing
- Dexmedetomidine Hydrochloride
- Where
- Japan
- Volunteers
- 111 people
- Sponsor
- Pfizer