Methadone in Pediatric and Adult Sickle Cell Patients
MSCD
1 other identifier
interventional
47
1 country
1
Brief Summary
To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 24, 2008
CompletedFirst Posted
Study publicly available on registry
September 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2010
CompletedResults Posted
Study results publicly available
January 22, 2020
CompletedJanuary 22, 2020
January 1, 2020
2.9 years
September 24, 2008
June 18, 2018
January 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.
R-Methadone AUC
96 hr
Secondary Outcomes (1)
Pain Relief
72 hr
Study Arms (4)
Methadone-Children
ACTIVE COMPARATORMethadone comparison to standard of care for pain management
Morphine-Children
ACTIVE COMPARATORMorphine standard of Care pain management
Methadone-Adults
ACTIVE COMPARATORMethadone comparison to standard of care for pain management
Morphine-Adults
ACTIVE COMPARATORMorphine standard of Care pain management
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barnes Jewish Hospital/St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Related Publications (1)
Horst J, Frei-Jones M, Deych E, Shannon W, Kharasch ED. Pharmacokinetics and analgesic effects of methadone in children and adults with sickle cell disease. Pediatr Blood Cancer. 2016 Dec;63(12):2123-2130. doi: 10.1002/pbc.26207. Epub 2016 Aug 30.
PMID: 27572136DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Evan Kharasch MD PhD
- Organization
- Washington University
Study Officials
- PRINCIPAL INVESTIGATOR
Evan D Kharasch, MD, PhD
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2008
First Posted
September 26, 2008
Study Start
January 1, 2008
Primary Completion
November 7, 2010
Study Completion
November 7, 2010
Last Updated
January 22, 2020
Results First Posted
January 22, 2020
Record last verified: 2020-01