NCT02447874RecruitingPhase 1/2
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
Arginine Therapy for the Treatment of Vaso-Occlusive Events in Children With Severe Sickle Cell Disease
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 15 May 2015
- Start date
- 1 May 2015
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Emory University
- Diseases
- Sickle cell disease
- NCT number
- NCT02447874
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 21
- From 1 May 2015 to the primary completion date, 31 Jan 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous hospitalization \< 7 days
Other illness
- Acute stroke or clinical concern for stroke
- Allergy to arginine
Lab values
- Diagnosis of sickle cell disease with any of the following types: hemoglobin SC disease (HbSC), hemoglobin beta thalassemia (Hb-Beta Thal), hemoglobin SD disease (HbSD), hemoglobin SE disease (HbSE), hemoglobin SO disease (HbSO), hemoglobin AS carrier (Hb AS)
- Hemoglobin less than 5 gm/dL
- Renal dysfunction: Creatinine \>1.0 or 2 x baseline
Other
- Decision to discharge home from acute care setting.
- Immediate Red cell transfusion anticipated
- Mental status or neurological changes
- Pregnancy
- Use of inhaled nitric oxide, sildenafil or arginine within the last 14 days
- Not an appropriate candidate in the investigator's judgement
Who the study is looking for
- Established diagnosis of sickle cell disease--Hemoglobin SS (Hb-SS) or Sβᴼ-thalassemia
- 7-21 years of age
- Weight \>= 25kg (55lbs)
- Pain requiring medical care in an acute care setting (emergency department (ED), hospital ward, day hospital, clinic) requiring parenteral opioids, not attributable to non-sickle cell causes.
Age in the registry: 7 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Healthcare fo Atlanta at Hughes Spalding Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Children's Healthcare of Atlanta at Arthur M. Blank Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.