Clinical trials: Sedation;
Pain, Cancer
A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy
GIC-1001 is a novel, orally-administered, colonic analgesic drug developed as an alternative to i.v. sedation during full colonoscopy.
- Conditions
- Pain, Cancer, Colonic Diseases
- Trial name
- NCT01926444
- Testing
- GIC-1001
- Where
- 15 sites in United States, Canada
- Volunteers
- 308 people
- Sponsor
- gicare Pharma Inc.
Perennial Allergic Rhinitis
A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)
This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with perennial allergic rhinitis.
- Trial name
- NCT01918033
- Testing
- Desloratadine 5 mg
- Volunteers
- 608 people
- Sponsor
- Organon and Co
Sedation
Multiple Dose Safety and Efficacy Study Evaluating CNS 7056 Versus Midazolam in Patients Undergoing Colonoscopy
The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy.
- Trial name
- NCT01145222
- Testing
- A. CNS 7056, B. CNS 7056, C. CNS 7056
- Where
- 9 sites in United States
- Volunteers
- 162 people
- Sponsor
- Paion UK Ltd.
Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy
Phase III Study of ICI35,868 (Diprivan) With and Without EES0000645/A (SDS) on Gastrointestinal Endoscopy
This study is designed as a multi-centre, randomised, parallel-group, placebo-controlled, phase III confirmatory study. The study will be partially double-blinded: the comparison between Group 1 (placebo group) and Group 2…
- Trial name
- Kagami_SDS (NCT01961349)
- Testing
- Intralipid, ICI35,868 (Diprivan), ICI35,868 (Diprivan) + EES0000645/A (SDS)
- Where
- 3 sites in Japan
- Volunteers
- 279 people
- Sponsor
- AstraZeneca
Procedural Sedation, Endoscopy
Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy
The purpose of this study was to assess the safety and efficacy of CNS 7056 as a procedural sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.
- Trial name
- NCT00869440
- Testing
- CNS 7056, Midazolam
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- Paion UK Ltd.
Sedation
Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine (DEX) in intubated and mechanically ventilated pediatric intensive care unit (PICU) subjects.
- Trial name
- NCT00875550
- Testing
- Dexmedetomidine, Midazolam, Fentanyl
- Where
- 37 sites in United States, Canada
- Volunteers
- 175 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Colonoscopy, Endoscopy, Digestive System
Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy
Patients routinely receive sedation during a colonoscopy or upper endoscopy (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during these procedures.
- Conditions
- Colonoscopy, Endoscopy, Digestive System, Conscious Sedation
- Trial name
- NCT00452426
- Testing
- Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System), benzodiazepines and opioid sedation
- Where
- 7 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Ethicon Endo-Surgery
Bronchoscopy
A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy
A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open label arm for midazolam, in patients undergoing a bronchoscopy.
- Trial name
- NCT02296892
- Testing
- Remimazolam, Midazolam
- Where
- 14 sites in United States
- Volunteers
- 446 people
- Sponsor
- Paion UK Ltd.
Sedation
Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation
The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine) in patients who require sedation during the surgery that requires epidural or spinal anesthesia without intubation under monitored…
- Trial name
- NCT01438957
- Testing
- Dexmedetomidine hydrochloride
- Where
- 12 sites in Japan
- Volunteers
- 119 people
- Sponsor
- Pfizer
MRI Sedation
Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
This is a randomized, double-blind, dose-ranging study of the efficacy and safety of dexmedetomidine (DEX) when used with propofol as needed, for procedural sedation of pediatric subjects ≥1 month to <17 years of age undergoing…
- Trial name
- NCT04237792
- Testing
- dexmedetomidine, propofol
- Where
- 23 sites in United States, Japan
- Volunteers
- 128 people
- Sponsor
- Pfizer
Ultrasound, CT Scans
Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation
The objective of this study is to evaluate the safety of dexmedetomidine in a pediatric population requiring non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS) for elective diagnostic or therapeutic…
- Conditions
- Ultrasound, CT Scans, MRIs
- Trial name
- NCT01519167
- Testing
- Dexmedetomidine, Midazolam, Fentanyl
- Where
- 11 sites in United States, Puerto Rico
- Volunteers
- 91 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Urticaria
An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)
This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with chronic urticaria. The primary hypothesis is that the efficacy of desloratadine 10 mg and 5 mg is superior to placebo as…
- Trial name
- NCT01916967
- Testing
- Desloratadine
- Volunteers
- 239 people
- Sponsor
- Organon and Co
Healthy
Simulated Driving Performance, Daytime Sedation and Cognition in Healthy Volunteers Taking Gralise, Neurontin or Lyrica
Phase 4, double-blind, placebo-controlled, four treatment, four sequence crossover study comparing simulated driving performance, daytime sedation and cognition in healthy volunteers administered therapeutic doses of Gralise®…
- Trial name
- NCT03179345
- Testing
- Gabapentin, Pregabalin
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Depomed
Sedation
Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old
This is a study to compare safety and efficacy of inhaled isoflurane delivered by the AnaConDa-S (Anaesthetic Conserving Device (ACD)) versus intravenous midazolam for sedation in mechanically ventilated children admitted to an…
- Trial name
- IsoCOMFORT (NCT04684238)
- Testing
- Midazolam, Isoflurane
- Where
- 24 sites in France, Germany and 3 more
- Volunteers
- 94 people
- Sponsor
- Sedana Medical
Anesthesia
SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation
The purpose of the study is to collect EEG data with the Masimo SedLine device along with vital signs, patient demographics, anesthetic record and surgical procedure during general anesthesia or sedation.
- Trial name
- NCT03128931
- Testing
- Pediatric SedLine forehead EEG sensor
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Masimo Corporation
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
Sedation
Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU2)
This is a study to compare safety and efficacy of inhaled isoflurane administered via the Sedaconda ACD-S device system versus intravenous propofol for sedation of mechanically ventilated patients in the Intensive Care Unit (ICU)…
- Trial name
- INSPiRE-ICU2 (NCT05327296)
- Testing
- Isoflurane, Propofol
- Where
- 16 sites in United States
- Volunteers
- 282 people
- Sponsor
- Sedana Medical
Sedation
Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age
The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading…
- Trial name
- NCT01159262
- Testing
- Midazolam, Fentanyl/Morphine, Dexmedetomidine
- Where
- 18 sites in United States, Guatemala
- Volunteers
- 36 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Anesthesia
Evaluation of Bispectral Index (BIS™) and Levels of Sedation With Common Inhalational Anesthetics in Healthy Volunteers (OLIVER)
To investigate the relationship between BIS™ and inhaled anesthetics across a wide range of anesthetic concentration and hypnotic states, and to provide evidence to support BIS™ performance in use with Isoflurane, Sevoflurane and…
- Trial name
- OLIVER (NCT04602546)
- Testing
- BIS Complete Monitoring System
- Where
- 3 sites in United States
- Volunteers
- 211 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Parkinson's Disease
Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine
This is a pilot study to explore the effects of pimavanserin and low-dose quetiapine in subjects with Parkinson's disease with neuropsychiatric symptoms.
- Trial name
- NCT04164758
- Testing
- Pimavanserin, Quetiapine
- Where
- 16 sites in United States
- Volunteers
- 11 people
- Sponsor
- ACADIA Pharmaceuticals Inc.