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)

NCT06635902 Phase 2 RECRUITING

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

Details

Lead sponsor	Suvankar Majumdar
Phase	Phase 2
Status	RECRUITING
Enrolment	99
Start date	2024-12-22
Completion	2029-03

Conditions

• Sickle Cell Disease
• Vaso-occlusive Pain Episode

Interventions

• L-citrulline
• Placebo
• L-citrulline

Primary outcomes

• Time-to-crisis resolution — Baseline to 30 days
  Change in time-to-crisis resolution as defined by the time (in hours) from first dose of intravenous study drug or placebo to the time of last dose of intravenous opioid during hospitalization

Countries

United States