Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635902
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Intravenous L-Citrulline for Vaso-occlusive Pain Episode in Sickle Cell Disease
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
This is a single-center phase 2 randomized double-blind placebo-controlled trial of intravenous L-citrulline for sickle cell patients ages 4 to 21 years experiencing a vaso-occlusive pain crisis episode VOE Eligible subjects will have a documented history of sickle cell disease and inpatient hospitalization for treatment of acute pain with parenteral opioid Subjects will be randomized to receive high dose intravenous L-citrulline low dose intravenous L-citrulline or placebo in addition to standard of care Subjects will be followed closely to evaluate time-to-crisis resolution as the primary outcome defined by time from first dose of intravenous study drugplacebo to the last dose of parenteral opioid prior to hospital discharge Participants will be monitored for any adverse events including 30-day re-hospitalization rates Total opioid consumption during the time-to-crisis resolution will be compared between the three arms In addition exploratory outcomes will be evaluated for pain score tissue blood flow genetic and candidate biomarkers related to vaso-occlusion
Objectives Primary Objective
To demonstrate the efficacy of intravenous L-citrulline in reducing the time-to-crisis resolution in sickle cell subjects experiencing a vaso-occlusive pain crisis episode VOE
Secondary Objectives
To evaluate the safety of intravenous L-citrulline in the treatment of VOE
To determine if intravenous L-citrulline improves cumulative opioid consumption during the treatment of VOE Exploratory Objectives
To determine if intravenous L-citrulline improves pain scores during the hospitalization
To determine if intravenous L-citrulline improves 30-day re-hospitalization rates
To determine the pharmacokinetic PK profile of intravenous L-citrulline
To evaluate whether intravenous L-citrulline improves tissue blood flow and candidate biomarkers related to vaso-occlusion
To assess whether genetic single nucleotide polymorphisms related to the nitric oxide pathway influence study outcomes
Objectives Primary Objective
To demonstrate the efficacy of intravenous L-citrulline in reducing the time-to-crisis resolution in sickle cell subjects experiencing a vaso-occlusive pain crisis episode VOE
Secondary Objectives
To evaluate the safety of intravenous L-citrulline in the treatment of VOE
To determine if intravenous L-citrulline improves cumulative opioid consumption during the treatment of VOE Exploratory Objectives
To determine if intravenous L-citrulline improves pain scores during the hospitalization
To determine if intravenous L-citrulline improves 30-day re-hospitalization rates
To determine the pharmacokinetic PK profile of intravenous L-citrulline
To evaluate whether intravenous L-citrulline improves tissue blood flow and candidate biomarkers related to vaso-occlusion
To assess whether genetic single nucleotide polymorphisms related to the nitric oxide pathway influence study outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None