NCT02447874 Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
| NCT ID | NCT02447874 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Emory University |
| Condition | Sickle Cell Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2015-05 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 21 participants in total. It began in 2015-05 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Decision to discharge home from acute care setting. * 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 * Immediate Red cell transfusion anticipated * Renal dysfunction: Creatinine \>1.0 or 2 x baseline * Mental status or neurological changes * Acute stroke or clinical concern for stroke * Pregnancy * Allergy to arginine * Previous hospitalization \< 7 days * Use of inhaled nitric oxide, sildenafil or arginine within the last 14 days * Not an appropriate candidate in the investigator's judgement
Contact & Investigator
Claudia Morris, MD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT02447874 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 21 Years, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02447874 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT02447874 currently recruiting?
Yes, NCT02447874 is actively recruiting participants. Contact the research team at Reshika.mendis@choa.org for enrollment information.
Where is the NCT02447874 trial being conducted?
This trial is being conducted at Atlanta, United States, Atlanta, United States.
Who is sponsoring the NCT02447874 clinical trial?
NCT02447874 is sponsored by Emory University. The principal investigator is Claudia Morris, MD at Emory University. The trial plans to enroll 21 participants.
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