Status:
COMPLETED
Efficacy of Opioids and Mexiletine for the Treatment of Postamputation Pain
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Amputation
Chronic Pain
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 p...
Detailed Description
The long-term objective of this research is to develop better clinical strategies for alleviating pain resulting from amputation of extremities. Amputation is the most radical form of nerve injury. Th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 1\) 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.
Key Trial Info
Start Date :
July 1 1997
Trial Type :
INTERVENTIONAL
End Date :
April 1 2003
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00383682
Start Date
July 1 1997
End Date
April 1 2003
Last Update
October 3 2006
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287