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Codeine in Sickle Cell Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00174538
First Posted: September 15, 2005
Last Update Posted: June 30, 2011
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.
Information provided by:
PriCara, Unit of Ortho-McNeil, Inc.
  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 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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
Estimated Study Completion Date: December 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

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
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
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


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

ClinicalTrials.gov Identifier: NCT00174538     History of Changes
Other Study ID Numbers: CR007111
FEN-EMR-4007
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: June 30, 2011
Last Verified: July 2005

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

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