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

Description

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

Conditions

Sickle Cell Disease, Vaso-occlusive Pain Episode

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Study Overview

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Study Details

Study overview

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

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)

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

Condition
Sickle Cell Disease
Intervention / Treatment

-

Contacts and Locations

Washington

Children's National Hospital, Washington, District of Columbia, United States, 20010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

4 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Suvankar Majumdar,

Suvankar Majumdar, MD, PRINCIPAL_INVESTIGATOR, Children's National Research Institute

Study Record Dates

2029-03