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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
PriCara, Unit of Ortho-McNeil, Inc.
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 9, 2005
Last Updated
June 29, 2011
Sponsor
PriCara, Unit of Ortho-McNeil, Inc.
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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

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Codeine in Sickle Cell Disease

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