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NCT03813277: Pedrux
Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU
Phase 4 trial testing Dexmedetomidine in ICU Sedation in 60 participants. Completed in 21 May 2018.
21 May 2018
Quick facts
| Lead sponsor | Orion Corporation, Orion Pharma |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 21 March 2017 |
| Primary completion | 21 May 2018 |
| Estimated completion | 21 May 2018 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Dexmedetomidine (dexmedetomidine) — full drug profile →
Conditions studied
- ICU Sedation — all drugs for ICU Sedation →
Sponsor
Orion Corporation, Orion Pharma — full company profile →
Who can join
Adults 12 to 17, any sex, with ICU Sedation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Open clinical trial to evaluate safety, tolerability, and efficacy of Dexdor for sedation in paediatric patients in intensive care settings. Multi-centre trial in Russia for marketing registration of Dexdor
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03813277
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Dexmedetomidine
Trials testing the same drug.
- NCT06824077 — Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle · EARLY_PHASE1 · not yet recruiting
- NCT07398066 — DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial) · NA · not yet recruiting
- NCT07377981 — An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyp · Phase 4 · not yet recruiting
- NCT07306702 — Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients · Phase 4 · withdrawn
- NCT07482540 — Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery · NA · not yet recruiting
Other Orion Corporation, Orion Pharma trials
Trials by the same sponsor.
- NCT06725758 — A Phase 1/2, First-in-Human Study On ODM-212 In Subjects With Selected Advanced Solid Tumours · Phase 1, PHASE2 · recruiting
- NCT06956495 — Efficacy and Tolerability of Tasipimidine in Sleepless Patients · Phase 2 · completed
- NCT05811039 — Efficacy and Safety of Remo-Wax® Oil (RWO) in Subjects With Isolated Itching of the External Ear Canal · NA · completed
- NCT05288075 — Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Test Products and Reference Product · Phase 1 · completed
- NCT05246046 — Comparison of Tiotropium Absorption From Tiotropium Easyhaler and Spiriva HandiHaler · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03813277 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Orion Corporation, Orion Pharma
- Last refreshed: 23 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03813277.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing