At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Randomized Control Trial of Arginine Therapy for Pediatric Sickle Cell Disease Pain
In Brief
A Phase 2 clinical trial evaluating L-arginine, L-arginine Loading Dose, and 1 other intervention for Sickle Cell Disease and Vaso-occlusive Pain Episode. Completed, enrolled 108 participants across 3 sites.
Detailed Summary
The aim of this study is to determine whether giving extra arginine, a simple amino acid, to patients with sickle cell disease seeking treatment for a pain crisis (vaso-occlusive painful events (VOE) will decrease pain scores, decrease the need for pain medications or decrease length of hospital stay or emergency department visit. Funding Source - FDA OOPD.
Study Details
Timeline
Interventions
L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.