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Codeine in Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT00174538
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : June 30, 2011
Sponsor:
Information provided by:
PriCara, Unit of Ortho-McNeil, Inc.

September 9, 2005
September 15, 2005
June 30, 2011
March 2005
Not Provided
  • Plasma morphine and codeine concentrations
  • CYP2D6 genotype
Same as current
Complete list of historical versions of study NCT00174538 on ClinicalTrials.gov Archive Site
  • Disease severity
  • Hospitalizations and admissions
Same as current
Not Provided
Not Provided
 
Codeine in Sickle Cell Disease
The Effects of Cytochrome P450 2D6 Genotype on Pain Management With Codeine in Sickle Cell Disease
The objective of this study is to determine if a subject's genetic make-up would affect the treatment response to codeine in subjects with sickle cell disease.
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 (i.e. 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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Sickle Cell Disease
Drug: Codeine (30 mg)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Same as current
December 2005
Not Provided

Inclusion Criteria:

  • Age >= 18 years old
  • Sickle cell disease (HbSS)
  • Hydrocodone- or codeine-containing medications to manage an acute pain crisis in the past

Exclusion Criteria:

  • Renal dysfunction, serum creatinine (SCr) > 2.0 mg/dl
  • Hepatic dysfunction, AST, ALT or direct bilirubin > 3 x upper limit of normal (ULN)
  • Codeine allergy
  • Medications shown to induce or inhibit CYP2D6
  • Women who are pregnant or breast feeding
  • Unable to provide written, informed consent
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00174538
CR007111
FEN-EMR-4007
Not Provided
Not Provided
Not Provided
Not Provided
PriCara, Unit of Ortho-McNeil, Inc.
Not Provided
Principal Investigator: Stacy S. Shord, PharmD University of Illinois at Chicago
PriCara, Unit of Ortho-McNeil, Inc.
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP