Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174538
Status:
COMPLETED
Last Update Posted:
2011-06-30
First Post:
2005-09-09
Brief Title:
Codeine in Sickle Cell Disease
Sponsor:
PriCara Unit of Ortho-McNeil Inc
Organization:
PriCara Unit of Ortho-McNeil Inc
Study Overview
Official Title:
The Effects of Cytochrome P450 2D6 Genotype on Pain Management With Codeine in Sickle Cell Disease
Status:
COMPLETED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to determine if a subjects genetic make-up would affect the treatment response to codeine in subjects with sickle cell disease
Detailed Description:
People with sickle cell disease require oral pain medications to manage an acute pain crisis Sometimes these individuals fail to obtain adequate pain relief with the medications prescribed for outpatient use resulting in emergency room visits and hospital admissions Subsequently many patients are admitted to the hospital for pain management for a few days until the pain crisis resolves The most common medications prescribed to sickle cell individuals for outpatient use include codeine and hydrocodone containing medications ie Tylenol 3 Vicodin Lortab These medications must be broken down in the body to make the active pain reliever morphine or hydromorphone respectively Some individuals may not be able to break down these medications to the active pain reliever therefore these individuals will likely continue to experience pain unless they take other pain medications We will determine whether genotype estimates the ability of CYP2D6 to break down codeine to the active pain reliever in individuals with sickle cell disease
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FEN-EMR-4007 | None | None | None |