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RecruitingPhase 2

Intravenous L-Citrulline for Vaso-occlusive Pain Episode in Sickle Cell Disease

A Phase 2 Randomized Double-blind, Placebo-controlled Clinical Trial of Intravenous Citrulline for Vaso-occlusive Pain Episode in Hospitalized Patients With Sickle Cell Disease (CONQUER SCD Pain Trial)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
4 Years to 21 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether L-citrulline given through a vein is safe and helps sickle cell pain end sooner. It is for patients ages 4 to 21 who are in the hospital for a sickle cell pain episode. Researchers will compare L-citrulline with a placebo, a look-alike treatment with no drug.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have any type of sickle cell disease.
  • Be 4 to 21 years old.
  • Have a sickle cell pain episode from blocked blood flow that needs hospital care and opioid pain medicine given by injection or through a vein.
  • Be able to start the study drug or placebo within 12 hours of the first injected or IV opioid dose in the emergency department.

Who can't join

  • Current pain has lasted more than 3 days, or more than 9 hospital stays in the past year.
  • Have another sickle cell problem that needs hospital care, such as blood trapped in the spleen or liver, a stroke, or a brief stroke-like episode. Also excluded: acute chest syndrome (a serious lung problem), sepsis (a dangerous response to infection), a bacterial infection, or unstable blood pressure or blood flow.
  • Have a history of opioid use disorder, long-term pain, or a treatment plan that requires daily opioid use.
  • Have severe anemia, meaning very low red blood cells: hemoglobin below 6 g/dL.
  • Are pregnant, confirmed by a urine test, or breastfeeding.
  • Have liver blood test levels (ALT or AST) above twice the normal upper limit for age, or these creatinine kidney test results: above 0.9 mg/dL at ages 4–13; 1.0 mg/dL at ages 14–17; above 1.5 mg/dL at age 18 or older.
  • Use L-glutamine.
  • Have had an allergic reaction to an L-citrulline product.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

DC