Inhaled Nitric Oxide for Pediatric Painful Sickle Crisis
NCT00142051 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2023-02-23
Summary
Randomized, double blind placebo controlled clinical trial to evaluate effectiveness and safety of inhaled nitric oxide for the treatment of sickle cell painful crisis in pediatric patients with sickle cell disease.
Conditions
Interventions
- DRUG
-
nitric oxide
80 ppm 8 hrs, 40 ppm 8 hrs, 20 ppm 4 hrs, 10 ppm 4 hrs
- DRUG
-
oxygen
oxygen fi02 21% (room air)
Sponsors & Collaborators
-
FDA Office of Orphan Products Development
collaborator FED - lead OTHER
Principal Investigators
-
Debra Weiner, MD, PhD · Boston Children's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 9 Years
- Max Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-04-30
- Primary Completion
- 2013-08-31
- Completion
- 2013-08-31
Countries
- United States
Study Locations
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