Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513864
Status:
WITHDRAWN
Last Update Posted:
2014-12-23
First Post:
2007-08-08
Brief Title:
Assessment of Opioid Analgesia in Sickle Cell
Sponsor:
Childrens National Research Institute
Organization:
Childrens National Research Institute
Study Overview
Official Title:
Non-Invasive Assessment of Opioid Analgesia in Children With Sickle Cell Disease
Status:
WITHDRAWN
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To develop and validate a non-invasive in vivo phenotyping method for CYP2D6 using the non-injurious neuroselective electrical stimulation technique pain perception thresholdpain tolerance threshold PPTPTT in children and adolescents with sickle cell disease
Detailed Description:
Codeine is a pro-drug with its analgesic activity being dependent on the metabolism of codeine to morphine The metabolism of codeine to morphine is catalyzed by the cytochrome P450 enzyme 2D6 CYP2D6 of which there are over 70 genetic variants leading to differing metabolic capabilities within populations It is hypothesized that the changes in PPTPTT will vary based on the individuals ability to convert morphine to codeine
Ineffective analgesic management of patients with sickle cell disease remains a major problem in the management of the disorder in both adults and children The pharmacological treatment of acute and chronic pain conditions resulting from vaso-occlusive crises in children with sickle cell disease typically involves the use of opioids In the outpatient setting this is most commonly achieved with administration of codeine andor tramadol both substrates of cytochrome P450 2D6 CYP2D6 Currently these drugs are used in this patient population without any information concerning the patients capacity to metabolize these CYP2D6 substrates which may lead to over and under treatment of pain depending on their CYP2D6 activity The proposed objectives in this application will address this issue by the development of a pharmacodynamic assessment tool that will objectively assess the response to morphine in terms of analgesic response pharmacodynamic assessment This new tool might also serve as a non-invasive technique for CYP2D6 phenotyping if CYP2D6 substrates are used for pain therapy by assessing specifically morphine response Development of this novel assessment tool will result in improved opioid analgesic therapy in this population Future anticipated studies will examine the application of this technique in the determination of opioid tolerance and hyperalgesia
Ineffective analgesic management of patients with sickle cell disease remains a major problem in the management of the disorder in both adults and children The pharmacological treatment of acute and chronic pain conditions resulting from vaso-occlusive crises in children with sickle cell disease typically involves the use of opioids In the outpatient setting this is most commonly achieved with administration of codeine andor tramadol both substrates of cytochrome P450 2D6 CYP2D6 Currently these drugs are used in this patient population without any information concerning the patients capacity to metabolize these CYP2D6 substrates which may lead to over and under treatment of pain depending on their CYP2D6 activity The proposed objectives in this application will address this issue by the development of a pharmacodynamic assessment tool that will objectively assess the response to morphine in terms of analgesic response pharmacodynamic assessment This new tool might also serve as a non-invasive technique for CYP2D6 phenotyping if CYP2D6 substrates are used for pain therapy by assessing specifically morphine response Development of this novel assessment tool will result in improved opioid analgesic therapy in this population Future anticipated studies will examine the application of this technique in the determination of opioid tolerance and hyperalgesia
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