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RECRUITING
NCT06635902
PHASE2

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

Sponsor: Suvankar Majumdar

View on ClinicalTrials.gov

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

Official title: 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)

Key Details

Gender

All

Age Range

4 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

99

Start Date

2024-12-22

Completion Date

2029-03

Last Updated

2025-04-17

Healthy Volunteers

No

Interventions

DRUG

L-citrulline

Intravenous L-citrulline (50 mg/kg + 9mg/kg/hr.) for 16 hours

OTHER

Placebo

Isotonic normal saline

DRUG

L-citrulline

Intravenous L-citrulline (25 mg/kg + 9mg/kg/hr.) for 16 hours

Locations (1)

Children's National Hospital

Washington D.C., District of Columbia, United States