Codeine in Sickle Cell Disease
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sickle Cell Disease |
Drug: Codeine (30 mg) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effects of Cytochrome P450 2D6 Genotype on Pain Management With Codeine in Sickle Cell Disease |
- Plasma morphine and codeine concentrations
- CYP2D6 genotype
- Disease severity
- Hospitalizations and admissions
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | December 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Illinois | |
| University of Illinois Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Principal Investigator: | Stacy S. Shord, PharmD | University of Illinois |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00174538 History of Changes |
| Other Study ID Numbers: | CR007111, FEN-EMR-4007 |
| Study First Received: | September 9, 2005 |
| Last Updated: | June 29, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by PriCara, Unit of Ortho-McNeil, Inc.:
|
codeine pain CYP2D6 genotype |
morphine sickle cell pharmacokinetic |
Additional relevant MeSH terms:
|
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Codeine Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics |
ClinicalTrials.gov processed this record on May 22, 2013