WHO ICTRP trial
The planned study is to determined the Esketamine’s efficacy (it's effectiveness…
EUCTR2018-001963-22-PL · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2018-001963-22-PL |
|---|---|
| Public title | The planned study is to determined the Esketamine’s efficacy (it's effectiveness and dose response) and pharmacokinetic properties (the fate of a substance in the body based on its concentration in the blood) and safety assessments (the occurrence of possible side effects) after multiple dose of inhaled Esketamine, compared to placebo in subject with treatment resistant depression in the course of major depressive disorder. |
| Scientific title | A multicentre, double-blind, randomised, placebo - controlled phase II study to assess efficacy, safety and pharmacokinetics of inhaled Esketamine in subject with treatment-resistant depression in the course of Major Depressive Disorder. |
| Primary sponsor | Celon Pharma SA |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Poland |
| Conditions | Eketamine, ketamine’s enantiomer, is designed for use in tretment resistant depression, both unipolar and bipolar. Many publications have demonstrated the effect of ketamine/esketamine (mainly administered intravenously) in treatment… |
| Interventions | Product Code: PG061 Pharmaceutical Form: Inhalation powder INN or Proposed INN: ESKETAMINE HYDROCHLORIDE CAS Number: 33643-47-9 Current Sponsor code: CZ06 Other descriptive name: ESKETAMINE HYDROCHLORIDE Concentration unit: mg milligram(s)… |
| Registration date | Jun 28, 2018 |
| Target size | 88 |
| Secondary IDs | 02KET2018 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: