Codeine in Sickle Cell Disease
Primary Purpose
Sickle Cell Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Codeine (30 mg)
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease focused on measuring codeine, pain, CYP2D6, genotype, morphine, sickle cell, pharmacokinetic
Eligibility 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
Sites / Locations
- University of Illinois Medical Center
Outcomes
Primary Outcome Measures
Plasma morphine and codeine concentrations
CYP2D6 genotype
Secondary Outcome Measures
Disease severity
Hospitalizations and admissions
Full Information
NCT ID
NCT00174538
First Posted
September 9, 2005
Last Updated
June 29, 2011
Sponsor
PriCara, Unit of Ortho-McNeil, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00174538
Brief Title
Codeine in Sickle Cell Disease
Official Title
The Effects of Cytochrome P450 2D6 Genotype on Pain Management With Codeine in Sickle Cell Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
PriCara, Unit of Ortho-McNeil, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
codeine, pain, CYP2D6, genotype, morphine, sickle cell, pharmacokinetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Codeine (30 mg)
Primary Outcome Measure Information:
Title
Plasma morphine and codeine concentrations
Title
CYP2D6 genotype
Secondary Outcome Measure Information:
Title
Disease severity
Title
Hospitalizations and admissions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy S. Shord, PharmD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Codeine in Sickle Cell Disease
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