Codeine in Sickle Cell Disease

Completed · Phase 1/Phase 2

Conditions studied: Sickle Cell Disease

In brief

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.

Key facts

Study ID

NCT00174538

Run by

PriCara, Unit of Ortho-McNeil, Inc.

People needed

60

Starts

2005-03-01

Expected to finish

2005-12-01

Last updated by the study team

2011-06-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >= 18 years old
• Sickle cell disease (HbSS)
• Hydrocodone- or codeine-containing medications to manage an acute pain crisis in the past

You may not qualify if…

• 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

Where it is running

• University of Illinois Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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