Codeine in Sickle Cell Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Sickle Cell Disease

Keywords

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codeine pain CYP2D6 genotype morphine sickle cell pharmacokinetic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Codeine (30 mg)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Stacy S. Shord, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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FEN-EMR-4007

Identifier Type: -

Identifier Source: secondary_id

CR007111