Codeine in Sickle Cell Disease

Sponsor

PriCara, Unit of Ortho-McNeil, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00174538

Collaborator

(none)

Enrollment

Location

Duration (Months)

6.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sickle Cell Disease	Drug: Codeine (30 mg)	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

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

Study Start Date :

Mar 1, 2005

Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

Plasma morphine and codeine concentrations []
CYP2D6 genotype []

Secondary Outcome Measures

Disease severity []
Hospitalizations and admissions []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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