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)

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Contact Information
Primary
Jillian Baker, RN
jbaker5@childrensnational.org
202-476-1311
Time Frame
Start Date: 2024-12-22
Estimated Completion Date: 2029-03
Participants
Target number of participants: 99
Treatments
Experimental: Low dose intravenous L-citrulline
Experimental: High dose intravenous L-citrulline
Placebo_comparator: Placebo
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: Suvankar Majumdar

This content was sourced from clinicaltrials.gov