Status:
TERMINATED
A Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain
Lead Sponsor:
MedtronicNeuro
Conditions:
Chronic Intractable Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and minimum effective dose of intraspinal gabapentin when delivered through an implanted drug infusion system.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Chronic pain below the neck present for a minimum of one year.
- Diagnosis of at least one of the following:
- back pain with or without leg pain,
- post-herpetic neuralgia,
- complex regional pain syndrome (CRPS) 1 or 2,
- diabetic neuropathy,
- or a general neuropathic condition; medically stable and able to undergo surgery for implantation of the drug infusion system.
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00414466
Start Date
December 1 2006
End Date
August 1 2010
Last Update
August 23 2013
Active Locations (14)
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1
Innovative Spine Care
Little Rock, Arkansas, United States, 72205
2
Napa Pain Institute
Napa, California, United States, 94558
3
Sarasota Pain Medicine Research
Sarasota, Florida, United States, 34238
4
WK River Cities Clinical Research Center
Shreveport, Louisiana, United States, 71105