Dettagli per singolo studio

DEC-NET Serial number FR427

Published online	24/06/2005 15.28.00
Last updated	27/11/2006 12.14.48

Other protocol ID number
Current trial status	Complete(closed to recruitment of participants: follow-up complete)
Major Disease (ICD9 class)	Aplastic anemia
Experimental drug
metoclopramide Treatment regimen (dosage and duration) Adults, teenagers and children more than 50 kg: 10 mg X 3/d orally Children less than 50 kg: 0,2 mg/kg X 3/d orally
Gender	Both
Age (range)	2 years or over
Eligibility criteria
Inclusion criteria
-Patients with Diamond-Blackfan anemia, dependent on a regular transfusional support (transfusion every 2 months). -Assent signed by the parents(if child) or the patient (if major)
Exclusion criteria
Only one of these criteria is sufficient to exclude the patient: -Patient younger than 2 years -Patient which follow-up will not be assured -Pregnancy -Any treated severe pathology (Diamond-Blackfan anemia exluded) -Contraindication for metoclopramide use: -chronic neurological disease. -treatment with levodopa or any dopaminergic agonists. -known hyperprolactinemia. -hypersensitivity to metoclopramide or one of its components. -previous dyskinesia with Primpéran® or other neuroleptic agents. -patient known or suspected to carry a pheochromocytoma. -gastro-intestinal disease in which stimulation of motricity may constitute a danger: mechanical obstruction, digestive haemorrhage, perforation. -personal or familial past history with potential increased risk of breast cancer.
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety Pharmacokinetics
Design	Controlled Randomised
Purpose of study
Primary objective: -To confirm the efficacy of metoclopramide in the treatment of children with Diamond-Blackfan anemia, in a cohort of patient registered in France from a controlled study. Secondary objectives: -To precise the delay of response by initially drawn lots. -To try to identify criteria to predict response. -To determine the kinetics of prolactin levels in all patients (good responders or non responders) taking into account the kinetics of other hormonal level. -To define the side effects of both metoclopramide and hyperprolactinemia in these patients.




Summary of study design, objectives, and ongoing research findings
The primary objective is to confirm the efficacy of metoclopramide in the treatment of children with Diamond-Blackfan anemia in a cohort of patients registered in France. The principal outcome is the need for transfusion, determined by the hemoglobin level.