Arginine Therapy for Sickle Cell Disease Pain
Completed · Phase 2 · Has a placebo group
Conditions studied: Sickle Cell Disease, Vaso-occlusive Pain Episode
In brief
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.
Key facts
- Study ID
- NCT02536170
- Run by
- Emory University
- People needed
- 108
- Starts
- 2016-02-01
- Expected to finish
- 2021-02-21
- Last updated by the study team
- 2023-09-06
Who can join
Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Established diagnosis of sickle cell disease (SCD); all genotypes
- Pain requiring medical care in an acute care setting (such as the emergency department or ED, hospital ward, day hospital, clinic) not attributable to non-sickle cell causes, that is moderate-to-severe requiring parenteral opioids
You may not qualify if…
- Decision to discharge home from the acute care setting
- Hemoglobin less than 5 gm/dL or immediate need for red cell transfusion anticipated within next 12 hours
- Hepatic dysfunction of SGPT greater than 3 times the upper value
- Renal dysfunction of creatinine greater than 1.0
- Mental status or neurological changes
- Acute stroke or clinical concern for stroke
- Pregnancy
- Allergy to arginine
- Two (2) or more ED visits for VOE within the last 7 days prior to CURRENT ED visit
- Hospitalization within 14 days
- Previous randomization in this arginine RCT (patient consented and screen failed before receiving study drug or placebo remains eligible for future participation).
- Use of inhaled nitric oxide, sildenafil or arginine within the last month
- PICU admission from the emergency department
- Hypotension requiring treatment with clinical intervention
- Acidosis with Co2≤ 16
- Newly started on HU for <3 months
- Not an appropriate candidate in the investigator's judgment
- Patient refusal
Where it is running
- Children's Healthcare of Atlanta at Hugh Spalding — Atlanta, Georgia, United States
- Children's Healthcare of Atlanta at Egleston — Atlanta, Georgia, United States
- Children's Healthcare of Atlanta at Scottish Rite — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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