Safety and Efficacy of Sodium Nitrite in Sickle Cell Disease
|Sickle Cell Disease||Drug: sodium nitrite injection, usp||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Safety and Efficacy Evaluation of Sodium Nitrite Injection for the Treatment of Vaso-Occlusive Crisis Associated With Sickle Cell Disease|
- 48 Hour Sodium Nitrite Infusion is Safe as Determined by no Adverse Events [ Time Frame: 48 hours from start of infusion ]The primary end points will be to determine if a) a 48-hour sodium nitrite infusion is tolerated without a decrease in mean arterial blood pressure by 15mmHg for greater than 2 hours or development of methemoglobin greater than 5% and b) a 48-hour sodium nitrite infusion is safe as determined by monitoring for adverse events
- Secondary End Point [ Time Frame: 48 hours ]a) reduced the duration and intensity of pain; b) reduced total narcotic analgesic consumption; and c) reduced length of hospitalization.
|Study Start Date:||December 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
No Intervention: No drug
No study drug administered
Experimental: Sodium nitrite injection, USP
Administration if sodium nitrite injection, USP
Drug: sodium nitrite injection, usp
Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose).
Other Name: sodium nitrite
Nitric oxide (NO) is a naturally occuring chemical that relaxes blood vessels and helps improve blood flow.
The pain associated with vaso-occlusive crisis (pain crisis) in sickle cell disease is caused in part by lack of oxygen and increased tissue acid because blood flow is blocked by stiff sickle red cells. Administration of sodium nitrite should generate nitric oxide in this area of hypoxia and acidosis and improve blood flow.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033227
|United States, California|
|Childrens Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|Principal Investigator:||Thomas Coates, MD||Children's Hospital Los Angeles|