drugset / Trial / NCT02447874
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
Phase 1/2
Recruiting
21 enrolled
Emory University
Children's Healthcare of Atlanta · collabNational Center for Complementary and Integrative Health (NCCIH) · collab
RandomizedCrossoverOpen-labelTreatment
Summary
The purpose of this study is to determine whether giving extra arginine to patients with sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease pain scores, decrease need for pain medications or decrease length of hospital stay or emergency department visit.
Timeline
- Start
- 2015-05
- Primary completion
- 2026-07
- Completion
- 2026-07
Publications
- Results Morris CR, Brown LAS, Reynolds M, Dampier CD, Lane PA, Watt A, Kumari P, Harris F, Manoranjithan S, Mendis RD, Figueroa J, Shiva S. Impact of arginine therapy on mitochondrial function in children with sickle cell disease during vaso-occlusive pain. Blood. 2020 Sep 17;136(12):1402-1406. doi: 10.1182/blood.2019003672.
- Results Korman R, Hatabah D, Brown LA, Harris F, Wilkinson H, Rees CA, Bakshi N, Archer DR, Dampier C, Morris CR. Impact of arginine therapy on kyotorphin in children with sickle cell disease and vaso-occlusive pain. Blood Adv. 2024 Jun 25;8(12):3267-3271. doi: 10.1182/bloodadvances.2023012209.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | L-arginine | Small molecule | 100 mg/kg | Intravenous |
| Subject | L-arginine | Small molecule | 300 mg/kg | Intravenous |