Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy
NCT ID: NCT02460107
Last Updated: 2017-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
EARLY_PHASE1
9 participants
INTERVENTIONAL
2015-05-31
2016-12-31
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
TRIPLE
Study Groups
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Normal saline
Normal saline
Normal saline
Placebo
Botulinum toxin type A 50U
Botulinum toxin 50U
Botulinum toxin type A
Botulinum toxin type A 100U
Botulinum toxin 100U
Botulinum toxin type A
Interventions
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Botulinum toxin type A
Normal saline
Placebo
Eligibility Criteria
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Inclusion Criteria
* patients should have 4 or more items positive among the 10 items of the DN4 questionnaire.
* persistence of neuropathic pain for more than three months or remission and recurrence of neuropathic pain for more than six months
* a pain score of 4 or more on the numeric rating scale
Exclusion Criteria
* contraindicated for botulinum toxin type A
* a change in pain medication one month prior to study enrollment
* a condition involving neuromuscular junction (Ex. Eaton Lambert disease, myasthenia gravis)
* person who received botulinum toxin type A within three months prior to study enrollment
20 Years
ALL
No
Sponsors
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Medy-Tox
INDUSTRY
Catholic University of Korea Saint Paul's Hospital
OTHER
Responsible Party
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Myung Eun Chung, MD, PhD
Catholic University of Korea Saint Paul's Hospital
Locations
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St. Paul's Hospital, The Catholic University of Korea
Seoul, , South Korea
Countries
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Other Identifiers
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CatholicUKSPH
Identifier Type: -
Identifier Source: org_study_id
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