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Codeine in Sickle Cell Disease
This study is currently recruiting participants.
Verified by PriCara, Unit of Ortho-McNeil, Inc., July 2005
Sponsored by: PriCara, Unit of Ortho-McNeil, Inc.
Information provided by: PriCara, Unit of Ortho-McNeil, Inc.
ClinicalTrials.gov Identifier: NCT00174538
  Purpose

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 Intervention Phase
Sickle Cell Disease
Drug: Codeine (30 mg)
Phase I
Phase II

Genetics Home Reference related topics: sickle cell disease
MedlinePlus related topics: Sickle Cell Anemia
Drug Information available for: Codeine Codeine phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title: The Effects of Cytochrome P450 2D6 Genotype on Pain Management With Codeine in Sickle Cell Disease

Further study details as provided by PriCara, Unit of Ortho-McNeil, Inc.:

Primary Outcome Measures:
  • Plasma morphine and codeine concentrations
  • CYP2D6 genotype

Secondary Outcome Measures:
  • Disease severity
  • Hospitalizations and admissions

Estimated Enrollment: 60
Study Start Date: March 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174538

Contacts
Contact: Stacy S. Shord, PharmD 312-413-3874 sshord@uic.edu
Contact: Robert E. Molokie, MD 312-569-8114 remoloki@uic.edu

Locations
United States, Illinois
University of Illinois Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Susan Cascio, BSN     312-996-7435     sacascio@uic.edu    
Sub-Investigator: Robert E. Molokie, MD            
Sub-Investigator: J. Louise Dorn, RN            
Sponsors and Collaborators
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
Principal Investigator: Stacy S. Shord, PharmD University of Illinois
  More Information

Study ID Numbers: FEN-EMR-4007
Study First Received: September 9, 2005
Last Updated: February 22, 2006
ClinicalTrials.gov Identifier: NCT00174538  
Health Authority: United States: Institutional Review Board

Keywords provided by PriCara, Unit of Ortho-McNeil, Inc.:
codeine
pain
CYP2D6
genotype
morphine
sickle cell
pharmacokinetic

Study placed in the following topic categories:
Morphine
Hematologic Diseases
Anemia
Anemia, Hemolytic
Pain
Sickle cell anemia
Codeine
Naphazoline
Oxymetazoline
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Guaifenesin
Phenylephrine
Hemoglobinopathies
Phenylpropanolamine
Hemoglobinopathy
Anemia, Sickle Cell

Additional relevant MeSH terms:
Respiratory System Agents
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Analgesics
Antitussive Agents
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009