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Sponsored by: |
PriCara, Unit of Ortho-McNeil, Inc. |
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Information provided by: | PriCara, Unit of Ortho-McNeil, Inc. |
ClinicalTrials.gov Identifier: | NCT00174538 |
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 |
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Sickle Cell Disease |
Drug: Codeine (30 mg) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | The Effects of Cytochrome P450 2D6 Genotype on Pain Management With Codeine in Sickle Cell Disease |
Estimated Enrollment: | 60 |
Study Start Date: | March 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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stacy S. Shord, PharmD | 312-413-3874 | sshord@uic.edu |
Contact: Robert E. Molokie, MD | 312-569-8114 | remoloki@uic.edu |
United States, Illinois | |
University of Illinois Medical Center | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Susan Cascio, BSN 312-996-7435 sacascio@uic.edu | |
Sub-Investigator: Robert E. Molokie, MD | |
Sub-Investigator: J. Louise Dorn, RN |
Principal Investigator: | Stacy S. Shord, PharmD | University of Illinois |
Study ID Numbers: | FEN-EMR-4007 |
Study First Received: | September 9, 2005 |
Last Updated: | February 22, 2006 |
ClinicalTrials.gov Identifier: | NCT00174538 |
Health Authority: | United States: Institutional Review Board |
codeine pain CYP2D6 genotype |
morphine sickle cell pharmacokinetic |
Morphine Hematologic Diseases Anemia Anemia, Hemolytic Pain Sickle cell anemia Codeine Naphazoline Oxymetazoline |
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Guaifenesin Phenylephrine Hemoglobinopathies Phenylpropanolamine Hemoglobinopathy Anemia, Sickle Cell |
Respiratory System Agents Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Antitussive Agents Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |