Codeine in Sickle Cell Disease

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PriCara, Unit of Ortho-McNeil, Inc.
• Treatments: Codeine

Criteria

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