Status:
COMPLETED
Codeine in Sickle Cell Disease
Lead Sponsor:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 outpat...
Eligibility Criteria
Inclusion
- Age \>= 18 years old
- Sickle cell disease (HbSS)
- Hydrocodone- or codeine-containing medications to manage an acute pain crisis in the past
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00174538
Start Date
March 1 2005
End Date
December 1 2005
Last Update
June 30 2011
Active Locations (1)
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1
University of Illinois Medical Center
Chicago, Illinois, United States, 60612