Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes
NCT ID: NCT00553592
Last Updated: 2007-11-05
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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UNKNOWN
PHASE2
336 participants
INTERVENTIONAL
2007-09-30
2008-12-31
Brief Summary
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To compare the tolerability of two dosages of bicifadine SR with placebo in adult outpaitens treated for chronic neuropathic pain for 14 weeks associated with diabetic peripheral neuropathy.
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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Drug
Bicifadine
Bicifadine
600mg/day
Drug: 2
Bicifadine
Bicifadine
1200 mg
Control
Placebo of Bicifadine
Bicifadine
placebo tablet
Interventions
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Bicifadine
600mg/day
Bicifadine
placebo tablet
Bicifadine
1200 mg
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of type-1 or type 2 non-insulin dependent diabetes mellitus
* Chronic bilateral pain due to diabetic neuropathy
* Pain for at least six months
* Primary pain is located in the feet
* Others-contact site for information
Exclusion Criteria
* Presence of amputations other than toes
* Clinically significant psychiatric or other neurological disorder
* Use of certain medications
* Clinically important other diseases
* Pregnancy
* History of alcohol or narcotic abuse within two years
* Others-contact site for information
18 Years
ALL
No
Sponsors
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XTL Biopharmaceuticals
INDUSTRY
Principal Investigators
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Mark Roffman, PhD
Role: STUDY_DIRECTOR
XTL Bio
Locations
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Four Rivers Clinical Research
Paducah, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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Jesse Wallace, MD
Role: primary
Caron Massey
Role: backup
Related Links
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Sponsor's website
Other Identifiers
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XTL B07-001
Identifier Type: -
Identifier Source: org_study_id