Intravenous L-Citrulline for Vaso-occlusive Pain Episode in Sickle Cell Disease (NCT06635902) | Clinical Trial Compass
RecruitingPhase 2
Intravenous L-Citrulline for Vaso-occlusive Pain Episode in Sickle Cell Disease
United States99 participantsStarted 2024-12-22
Plain-language summary
The goal of this clinical trial is to learn if intravenous citrulline works to treat acute pain in hospitalized patients with sickle cell disease. It will also learn about the safety of intravenous citrulline. The main questions it aims to answer are:
* Does intravenous citrulline decrease the duration of sickle cell pain during hospitalization
* What medical problems do participants have when taking intravenous citrulline? Researchers will compare intravenous citrulline to a placebo (a look-alike substance that contains no drug) to see if intravenous citrulline works to treat acute pain.
Participants will:
* Receive baseline tests and intravenous citrulline for 16 hours during the hospital stay
* After hospital discharge, visit the clinic in about 30 days for checkup and tests
Who can participate
Age range
4 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Sickle cell disease (all genotypes)
* Patients with sickle cell disease ages 4 to 21 years old
* Presence of sickle cell vaso-occlusive pain episode requiring hospitalization and parenteral opioid therapy
* Able to randomize to study drug/placebo within 12 hours of first dose of parenteral opioid in the Emergency Department
Exclusion Criteria:
* Current pain lasting \>3 days.
* \>9 hospitalizations in the prior year
* Presence of any other complication related to sickle cell disease requiring the hospitalization such as splenic sequestration, hepatic sequestration, stroke, transient ischemic attack, etc.
* History of opioid use disorder, chronic pain or medical regimen requiring daily opioid use.
* Severe anemia (hemoglobin \<6g/dL)
* Pregnant (as confirmed by a positive urine pregnancy test) or lactating female.
* Alanine/aspartate transferase \>2x upper limit of normal laboratory range for age.
* Subject has the following serum creatinine:
* Age 4 to 13 years \> 0.9 mg/dL
* Age 14 to 17 years 1.0 mg/dL
* Age ≥18 years \>1.5mg/dL
* Presence of acute chest syndrome, sepsis, bacterial infection, hemodynamic instability
* Use of L-glutamine
* History of allergic reaction to L-citrulline products
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.