A Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain
NCT ID: NCT00414466
Last Updated: 2013-08-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
254 participants
INTERVENTIONAL
2006-12-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo (0mg/day)
Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
Intraspinal Gabapentin
Surgical implantation of a drug infusion system with intrathecal (spinal) delivery of active drug (1 of 3 possible dose levels) or placebo (saline) for 22 days followed by 7 days of infusion at half dose level. Subjects may then continue in open-label treatment with study drug. Dosage in open-label may be adjusted to meet subject needs.
Gabapentin Low (1mg/day)
Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Intraspinal Gabapentin
Surgical implantation of a drug infusion system with intrathecal (spinal) delivery of active drug (1 of 3 possible dose levels) or placebo (saline) for 22 days followed by 7 days of infusion at half dose level. Subjects may then continue in open-label treatment with study drug. Dosage in open-label may be adjusted to meet subject needs.
Gabapentin Medium (6mg/day)
Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Intraspinal Gabapentin
Surgical implantation of a drug infusion system with intrathecal (spinal) delivery of active drug (1 of 3 possible dose levels) or placebo (saline) for 22 days followed by 7 days of infusion at half dose level. Subjects may then continue in open-label treatment with study drug. Dosage in open-label may be adjusted to meet subject needs.
Gabapentin High (30mg/day)
Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Intraspinal Gabapentin
Surgical implantation of a drug infusion system with intrathecal (spinal) delivery of active drug (1 of 3 possible dose levels) or placebo (saline) for 22 days followed by 7 days of infusion at half dose level. Subjects may then continue in open-label treatment with study drug. Dosage in open-label may be adjusted to meet subject needs.
Interventions
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Intraspinal Gabapentin
Surgical implantation of a drug infusion system with intrathecal (spinal) delivery of active drug (1 of 3 possible dose levels) or placebo (saline) for 22 days followed by 7 days of infusion at half dose level. Subjects may then continue in open-label treatment with study drug. Dosage in open-label may be adjusted to meet subject needs.
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Locations
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Innovative Spine Care
Little Rock, Arkansas, United States
Napa Pain Institute
Napa, California, United States
Sarasota Pain Medicine Research
Sarasota, Florida, United States
WK River Cities Clinical Research Center
Shreveport, Louisiana, United States
MAPS Applied Research Center
Edina, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
U B Neurosurgery, Inc.
Buffalo, New York, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Pain Research of Oregon, LLC
Eugene, Oregon, United States
Oregon Health & Science University, Neurosurgery Department
Portland, Oregon, United States
Lehigh Valley Hospital Center for Pain Management
Allentown, Pennsylvania, United States
Pinnacle Pain Medicine
Dallas, Texas, United States
Axis Spine Care/Texas Spine & Joint
Tyler, Texas, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
Countries
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References
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Rauck R, Coffey RJ, Schultz DM, Wallace MS, Webster LR, McCarville SE, Grigsby EJ, Page LM. Intrathecal gabapentin to treat chronic intractable noncancer pain. Anesthesiology. 2013 Sep;119(3):675-86. doi: 10.1097/ALN.0b013e3182a10fbf.
Other Identifiers
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1622
Identifier Type: -
Identifier Source: org_study_id