Skip to main content
OpenTrials
Completed

NCT Number: NCT00174538

Codeine in Sickle Cell Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Illinois Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Codeine (30 mg)

Drug

Primary outcomes

  1. Plasma morphine and codeine concentrations

  2. CYP2D6 genotype

Secondary outcomes

  1. Disease severity

  2. Hospitalizations and admissions

Sponsors and collaborators

Lead sponsor

PriCara, Unit of Ortho-McNeil, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Jun 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.