14 completed, 1 active not recruiting, 1 terminated. 7 Phase 3, 5 Phase 1, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 5, Active not recruiting 1, Terminated 1 |
| Phase 1 | 5 | Completed 5 |
| Phase 2 | 5 | Completed 4, Active not recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures Remimazolam - Pediatric ALL | Phase 2 / Phase 3 | Active not recruiting | Acacia Pharma Ltd | 100 | 2021-11-15 | 2025-07-01 |
| Assessment of the Pharmacodynamic and Pharmacokinetic Interaction of Remimazolam and Remifentanil Remimazolam, Remifentanil - Anesthesia | Phase 1 | Completed | Paion UK Ltd. | 28 | 2021-04-13 | 2023-09-11 |
| REmimazolam Infusion in the Context of Hypnotic Shortage in the Critical Care Unit During the Pandemic of COVID-19: REHSCU Study Remimazolam - Acute Respiratory Failure, COVID-19 | Phase 2 | Completed | Nantes University Hospital | 30 | 2020-11-30 | 2021-11-04 |
| Efficacy and Safety of Remimazolam (CNS7056) Compared to Propofol for Intravenous Anesthesia During Elective Surgery Remimazolam, Propofol - Anesthesia, Intravenous | Phase 3 | Completed | Paion UK Ltd. | 469 | 2018-07-24 | 2020-05-28 |
| Oral Remimazolam With and Without Alcohol in Healthy Female Subjects Remimazolam, Alcohol - Safety Issues | Phase 1 | Completed | Paion UK Ltd. | 21 | 2017-05-30 | 2019-10-02 |
| A Trial of Intranasal Remimazolam Pharmacokinetics, Pharmacodynamics, Safety and Bioavailability Remimazolam, Placebo - Procedural Sedation | Phase 1 | Completed | Paion UK Ltd. | 12 | 2017-05-15 | 2019-04-04 |
| Absolute Oral Bioavailability of Remimazolam Remimazolam - Bioavailability | Phase 1 | Completed | Paion UK Ltd. | 14 | 2015-11-03 | 2019-10-02 |
| Safety and Efficacy of Remimazolam in ASA III and IV Patients Undergoing Colonoscopy Remimazolam, Midazolam, Placebo - Colonoscopy | Phase 3 | Completed | Paion UK Ltd. | 79 | 2015-11-01 | 2020-09-30 |
| Study of the Efficacy and Safety of Remimazolam in General Anesthesia in Adults Undergoing Cardiac Surgery Propofol, Remimazolam - Anesthesia | Phase 3 | Terminated | Paion UK Ltd. | 25 | 2015-07-01 | 2023-08-30 |
| Abuse Potential of Intravenous Remimazolam Compared to Midazolam and Placebo in Recreational CNS Depressant Users Remimazolam, Midazolam, Saline - Abuse, Drug | Phase 1 | Completed | Paion UK Ltd. | 83 | 2015-06-23 | 2019-10-01 |
| A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy Remimazolam, Placebo, Midazolam - Bronchoscopy | Phase 3 | Completed | Paion UK Ltd. | 446 | 2015-04-01 | 2020-03-18 |
| A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients Remimazolam, Midazolam, Placebo - Colonoscopy | Phase 3 | Completed | Paion UK Ltd. | 461 | 2015-03-30 | 2020-10-20 |
| Remimazolam Phase II Cardiac Anesthesia Study Remimazolam, Propofol, Sevoflurane - General Anesthesia | Phase 2 | Completed | Paion UK Ltd. | 90 | 2013-08-01 | 2020-01-18 |
| Multiple Dose Safety and Efficacy Study Evaluating CNS 7056 Versus Midazolam in Patients Undergoing Colonoscopy A. CNS 7056, B. CNS 7056, C. CNS 7056 - Sedation | Phase 2 | Completed | Paion UK Ltd. | 162 | 2010-05-01 | 2019-01-08 |
| Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy CNS 7056, Midazolam - Procedural Sedation, Endoscopy | Phase 2 | Completed | Paion UK Ltd. | 100 | 2009-03-01 | 2019-01-08 |
| An Efficacy and Safety Study to Compare Morphine 6-glucuronide (M6G) and Morphine in Patients Suffering With Post-Operative Pain for at Least 24 Hours Morphine 6-glucuronide, Morphine - Postoperative Pain | Phase 3 | Completed | Paion UK Ltd. | 517 | 2005-11-01 | 2023-08-29 |
COVID-19 (1) · Pain, Postoperative (1) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (1) · Sepsis (1) · Shock (1) · Stroke (1) · Substance-Related Disorders (1) · Vomiting (1) · Wounds and Injuries (1)
remimazolam (15) · Midazolam (5) · Propofol (3) · Remifentanil (2) · Ethanol (1) · Fentanyl (1) · Injections (1) · Morphine (1) · Rocuronium (1) · Sevoflurane (1) · Sodium Chloride (1) · Solutions (1) · WW Domain-Containing Oxidoreductase (1) · morphine-6-glucuronide (1)
United States (10) · Germany (4) · France (2) · Netherlands (2) · Czechia (1) · Denmark (1) · Poland (1) · United Kingdom (1)
Shawn Searle, MD (2) · Stefan Probst, MD (2) · Ahad Sabet, MD (1) · Alexander Binning, M.D. (1) · Douglas K Rex, MD (1) · Douglas Rex, MD (1) · Gerard Silvestri, MD (1) · James Lees, B.Sc. (1) · Remco Vellinga, MD (1) · Shawn Searly, M.D (1)
PMID 32757149, PMID 25502841, PMID 26363333, PMID 29723512, PMID 30292760, PMID 40067039, PMID 40174701
2005 (1)