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Methadone in Pediatric and Adult Sickle Cell Patients (MSCD)

This study is currently recruiting participants.
Verified March 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00761085
First received: September 24, 2008
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.


Condition Intervention
Sickle Cell Disease
 Drug: Morphine
Drug: Methadone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Methadone in Pediatric and Adult Sickle Cell Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • To determine the pharmacokinetics of methadone in children and adults with Sickle Cell disease experiencing a VOE. [ Time Frame: November 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain [ Time Frame: November 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: January 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Comparison to standard of care for pain management
 Drug: Methadone
Methadone given to compare to standard of care for pain management
Drug: Methadone
Patients are randomized to either receive standard of care or methadone for pain management of acute episode of pain.
Active Comparator: 2
Standard of Care pain management
 Drug: Morphine
Standard of care for pain management of acute episode of pain

  Eligibility

Ages Eligible for Study:   7 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than or equal to 7 years and less than or equal to 40 years
  • Confirmed diagnosis of any form of sickle cell disease, including sickle cell anemia, sickle-hemoglobin C disease, and sickle-B thalassemia
  • Currently experiencing a vaso-occlusive episode (VOE), defined as acute pain in the extremities
  • Admitted to the inpatient unit for further treatment
  • Started on morphine patient controlled analgesia and infusion for pain management

Exclusion Criteria:

  • Diagnosis of acute chest syndrome
  • New focal neurologic findings or clinical concern of stroke
  • Aplastic crisis with hemoglobin 2 g/dl below steady-state value
  • Allergy to morphine or methadone
  • Any other medical condition that the attending physician deems to be a contraindication to therapy
  • Liver or renal insufficiency or failure, and congestive heart failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761085

Locations
United States, Missouri
Barnes Jewish Hospital/St. Louis Children's Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Evan D Kharasch, MD, PhD     314-362-7551     kharasch@wustl.edu    
Contact: Jane Blood, RN     314-747-5531     bloodj@wust.edu    
Principal Investigator: Evan D Kharasch, MD, PhD            
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Evan D Kharasch, MD, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00761085     History of Changes
Other Study ID Numbers: 07-0938
Study First Received: September 24, 2008
Last Updated: March 1, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Methadone
Morphine
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 19, 2013