Codeine in Sickle Cell Disease

This study has been completed.
Sponsor:
Information provided by:
PriCara, Unit of Ortho-McNeil, Inc.
ClinicalTrials.gov Identifier:
NCT00174538
First received: September 9, 2005
Last updated: June 29, 2011
Last verified: July 2005
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00174538     History of Changes
Other Study ID Numbers: CR007111, FEN-EMR-4007
Study First Received: September 9, 2005
Last Updated: June 29, 2011
Health Authority: United States: Institutional Review Board

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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on April 17, 2014