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Codeine in Sickle Cell Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date June 30, 2011
Study Start Date  ICMJE March 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • Plasma morphine and codeine concentrations
  • CYP2D6 genotype
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • Disease severity
  • Hospitalizations and admissions
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Codeine in Sickle Cell Disease
Official Title  ICMJE The Effects of Cytochrome P450 2D6 Genotype on Pain Management With Codeine in Sickle Cell Disease
Brief Summary 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.
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 (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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE Drug: Codeine (30 mg)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 9, 2005)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00174538
Other Study ID Numbers  ICMJE CR007111
FEN-EMR-4007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE PriCara, Unit of Ortho-McNeil, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stacy S. Shord, PharmD University of Illinois at Chicago
PRS Account PriCara, Unit of Ortho-McNeil, Inc.
Verification Date July 2005

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