Study Summary
This trial will test whether giving extra arginine to sickle cell patients during a vaso-occlusive event will decrease pain.
- Sickle Cell Disease
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 12 Secondary · Reporting Duration: Day 1 through study completion, an average of up to 7 days
Trial Safety
Phase-Based Safety
Side Effects for
Awards & Highlights
Trial Design
3 Treatment Groups
Standard dose
1 of 3
Loading dose + continuous infusion
1 of 3
Loading dose + standard dose
1 of 3
Experimental Treatment
21 Total Participants · 3 Treatment Groups
Primary Treatment: Arginine · No Placebo Group · Phase 1 & 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 7 - 21 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Morris, Claudia R., Lou Ann S. Brown, Michael Reynolds, Carlton D. Dampier, Peter A. Lane, Amanda Watt, Polly Kumari, et al.. 2020. “Impact of Arginine Therapy on Mitochondrial Function in Children with Sickle Cell Disease During Vaso-occlusive Pain”. Blood. American Society of Hematology. doi:10.1182/blood.2019003672.
- Morris, Claudia R., Lou Ann S. Brown, Michael Reynolds, Carlton D. Dampier, Peter A. Lane, Amanda Watt, Polly Kumari, et al.. 2020. “Impact of Arginine Therapy on Mitochondrial Function in Children with Sickle Cell Disease During Vaso-occlusive Pain”. Blood. American Society of Hematology. doi:10.1182/blood.2019003672.
- Claudia R. Morris 2015. "Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02447874.
Frequently Asked Questions
Are there any vacancies for participants in this clinical trial?
"Correct. Clinicaltrials.gov records show that this medical trial, which was initialy posted on the 1st of May 2015 and last updated on 22nd April 2022 is now accepting participants. Approximately 21 people are needed from two distinct locations for enrollment into this study." - Anonymous Online Contributor
Is this trial the inaugural venture of its kind?
"Presently, 14 trials evaluating Arginine are in progress across 24 cities and 11 distinct nations. This drug's clinical journey began with Baxter Healthcare Corporation sponsoring a Phase 4 study back in 2007; the research involved 4640 test-subjects and was ultimately successful. Subsequently, 58 further investigations have been conducted over the intervening years." - Anonymous Online Contributor
What are the criteria for eligibility in this trial?
"This medical trial requires 21 participants aged between 7 and 21, who have anemia caused by sickle cell disease. Additionally, they must weigh at least 25 kg (55lbs) and require opioid medications to manage the pain associated with their condition due to a visit to an emergency department or clinic." - Anonymous Online Contributor
Have there been previous experiments regarding Arginine's effects?
"Currently, 14 trials are investigating the effects of Arginine with 4 studies in their final phase. While most investigations for this substance occur out of Santiago, Región Metropolitana, there are 41 different sites observing its properties." - Anonymous Online Contributor
How many human participants have registered for this research effort?
"Affirmative. As per clinicaltrials.gov, this medical experiment is enrolling participants at the present time. Originally posted on May 1st 2015, it was most recently updated on April 22nd 2022 and requires 21 patients from 2 separate locations to complete the trial." - Anonymous Online Contributor
Is there an age restriction on the participants of this trial?
"This research is in search of participants aged 7 or above but under 21 years old." - Anonymous Online Contributor
What therapeutic applications is Arginine typically applied to?
"Arginine is a popular treatment for pituitary dwarfism, as well as conditions related to deficient enzymes, inadequate stimulation of the pituitary gland, and amino acid deficiency." - Anonymous Online Contributor