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Trial record 12 of 48 for:    Recruiting, Not yet recruiting, Available Studies | methadone

Methadone in Pediatric and Adult Sickle Cell Patients (MSCD)

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ClinicalTrials.gov Identifier: NCT00761085
Recruitment Status : Recruiting
First Posted : September 26, 2008
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: Morphine Drug: Methadone Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Methadone in Pediatric and Adult Sickle Cell Patients
Study Start Date : January 2008
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Active Comparator: Methadone
Methadone comparison to standard of care for pain management
Drug: Methadone
Methadone given to compare to standard of care for pain management

Active Comparator: Morphine
Mophine standard of Care pain management
Drug: Morphine
Standard of care for pain management of acute episode of pain




Primary Outcome Measures :
  1. To determine the pharmacokinetics of methadone in children and adults with Sickle Cell disease experiencing a VOE. [ Time Frame: November 2009 ]

Secondary Outcome Measures :
  1. Pain [ Time Frame: November 2009 ]


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Ages Eligible for Study:   7 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00761085     History of Changes
Other Study ID Numbers: 201107091
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Methadone
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents