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Codeine in Sickle Cell Disease

The Effects of Cytochrome P450 2D6 Genotype on Pain Management With Codeine in Sickle Cell Disease

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00174538
Enrollment
60
Registered
2005-09-15
Start date
2005-03-31
Completion date
2005-12-31
Last updated
2011-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Keywords

codeine, pain, CYP2D6, genotype, morphine, sickle cell, pharmacokinetic

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.

Interventions

DRUGCodeine (30 mg)

Sponsors

PriCara, Unit of Ortho-McNeil, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Plasma morphine and codeine concentrations
CYP2D6 genotype

Secondary

MeasureTime frame
Disease severity
Hospitalizations and admissions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026