WHO ICTRP trial
BETADOSE: Dose reduction of antenatal betamethasone given to prevent the…
EUCTR2016-001486-90-FR · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2016-001486-90-FR |
|---|---|
| Public title | BETADOSE : Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth: a randomized, multicenter, double blind placebo-controlled non inferiority trial |
| Scientific title | Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth: a randomized, multicentre, double blind placebo-controlled non inferiority trial. BETADOSE - BETADOSE |
| Primary sponsor | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) |
| 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): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | France |
| Conditions | Very preterm birth MedDRA version: 19.0 Level: LLT Classification code 10053593 Term: Premature baby 26 to 32 weeks System Organ Class: 100000004868 ;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems… |
| Interventions | Trade Name: CELESTENE CHRONODOSE 5,70 mg/ml, suspension injectable Product Name: CELESTENE CHRONODOSE 5,70 mg/ml, suspension injectable Pharmaceutical Form: Suspension for injection INN or Proposed INN: Bétaméthasone Other descriptive name… |
| Registration date | Apr 27, 2016 |
| Target size | 3142 |
| Secondary IDs | P150944 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: