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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
Information provided by:
PriCara, Unit of Ortho-McNeil, Inc.

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: Codeine (30 mg) Phase 1 Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Cytochrome P450 2D6 Genotype on Pain Management With Codeine in Sickle Cell Disease
Study Start Date : March 2005
Estimated Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Codeine
U.S. FDA Resources

Primary Outcome Measures :
  1. Plasma morphine and codeine concentrations
  2. CYP2D6 genotype

Secondary Outcome Measures :
  1. Disease severity
  2. Hospitalizations and admissions

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00174538

United States, Illinois
University of Illinois Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
PriCara, Unit of Ortho-McNeil, Inc.
Principal Investigator: Stacy S. Shord, PharmD University of Illinois at Chicago

ClinicalTrials.gov Identifier: NCT00174538     History of Changes
Other Study ID Numbers: CR007111
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: June 30, 2011
Last Verified: July 2005

Keywords provided by PriCara, Unit of Ortho-McNeil, Inc.:
sickle cell

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents