Efficacy of Opioids and Mexiletine for the Treatment of Postamputation Pain
Randomized, Placebo-Controlled, Double-Blind Cross-Over Trial of Opioids Versus Mexiletine in the Treatment of Postamputation Pain
2 other identifiers
interventional
60
1 country
1
Brief Summary
Persistent pain occurs in 50-85 percent of patients who experience the amputation of an extremity. This study will compare the effectiveness of morphine and mexiletine to placebo in the treatment of postamputation pain. It is hypothesized that the effects of opioids and mexiletine on behavior and mental functioning in patients with postamputation pain are unlikely to be significant barriers to the clinical use of the drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 1997
Longer than P75 for phase_2
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
July 1, 1997
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 29, 2006
CompletedFirst Posted
Study publicly available on registry
October 3, 2006
CompletedOctober 3, 2006
September 1, 2006
September 29, 2006
September 29, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain intensity (0-10 numerical rating scale)
Secondary Outcomes (2)
Pain relief (0-100%)
Functional activity (Multidimensional Pain Inventory activity and interference subscales
Interventions
Eligibility Criteria
You may qualify if:
- Adults (18 years or older) of both sexes and all races with persistent phantom and or stump pain for 6 months or longer following an amputation will be eligible for enrollment in the study.
You may not qualify if:
- \) age less than 18 or over 85 years, 2) history of allergic reaction to the study drugs, i.e., morphine and mexiletine, 3) cardiac conduction defects such as second degree or complete heart block, or a myocardial infarction in the last 3 months, 4) severe pulmonary disease, 5) current history of alcohol or substance abuse, 6) seizures, dementia or encephalopathy, 7) pregnancy and nursing mothers, 8) chronic hepatic disease or hepatic failure, 9) hematological disease associated with leukopenia and/or thrombocytopenia, and 10) other terminal illness with a life expectancy of less than 6 months. 11) Finally, to avoid a bias in patient selection, patients who failed to achieve clinically significant pain relief to a previous optimal trial with morphine and/or mexiletine will be excluded. An optimal trial will be defined as minimum of 3 week trial with either agent using a drug titration paradigm where the dose of the drugs were increased at intervals of one week or less.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Related Publications (1)
Wu CL, Agarwal S, Tella PK, Klick B, Clark MR, Haythornthwaite JA, Max MB, Raja SN. Morphine versus mexiletine for treatment of postamputation pain: a randomized, placebo-controlled, crossover trial. Anesthesiology. 2008 Aug;109(2):289-96. doi: 10.1097/ALN.0b013e31817f4523.
PMID: 18648238DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Srinivasa N Raja, M.D.
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 29, 2006
First Posted
October 3, 2006
Study Start
July 1, 1997
Study Completion
April 1, 2003
Last Updated
October 3, 2006
Record last verified: 2006-09