Codeine in Sickle Cell Disease

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174538
• Other study ID #: CR007111
• Secondary ID: FEN-EMR-4007
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 9, 2005
• Last updated: June 29, 2011
• Start date: March 2005
• Est. completion date: December 2005

Study information

• Verified date: July 2005
• Source: PriCara, Unit of Ortho-McNeil, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Drug:
• Codeine (30 mg)

Locations

Country	Name	City	State
United States	University of Illinois Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
PriCara, Unit of Ortho-McNeil, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma morphine and codeine concentrations
Primary	CYP2D6 genotype
Secondary	Disease severity
Secondary	Hospitalizations and admissions