NCT06635902RecruitingPhase 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)
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 99 (estimated)
- First submitted
- 7 Oct 2024
- Start date
- 22 Dec 2024
- Primary completion date
- Jun 2028
- Lead sponsor
- Suvankar Majumdar
- Diseases
- Sickle cell disease
- NCT number
- NCT06635902
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 99
- From 22 Dec 2024 to the primary completion date, Jun 2028
- 1 site 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
- \>9 hospitalizations in the prior year
Other illness
- 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.
- Presence of acute chest syndrome, sepsis, bacterial infection, hemodynamic instability
- History of allergic reaction to L-citrulline products
Lab values
- Severe anemia (hemoglobin \<6g/dL)
- 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
Other
- Current pain lasting \>3 days.
- Pregnant (as confirmed by a positive urine pregnancy test) or lactating female.
- Use of L-glutamine
Who the study is looking for
- 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
Age in the registry: 4 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's National Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.