A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
NCT ID: NCT00597649
Last Updated: 2009-06-30
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
PHASE2
250 participants
INTERVENTIONAL
2007-10-31
2008-12-31
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
NONE
Study Groups
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1
Bicifadine 800 mg/day for a year
Bicifadine
SR dosage form of 400 mg bid or tid for one year
2
Bicifadine 1200 mg/day for a year
Bicifadine
SR dosage form of 400 mg bid or tid for one year
Interventions
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Bicifadine
SR dosage form of 400 mg bid or tid for one year
Eligibility Criteria
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Inclusion Criteria
* 18 years or older
* 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.
* Subject participated in and completed the XTL 07-001 clinical trial.
Contact site for additional information.
Exclusion Criteria
* Presence of amputations other than toes
* Clinically significant psychiatric or other neuropsychological disorder
* Use of certain medications
* Clinically important other diseases
* Pregnancy
* History of alcohol or narcotic abuse within two years.
Contact site for additional information.
18 Years
90 Years
ALL
No
Sponsors
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XTL Biopharmaceuticals
INDUSTRY
Responsible Party
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XTL Biopharmaceutical Co.
Principal Investigators
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Mark Roffman, PhD
Role: STUDY_DIRECTOR
XTL Biopharmaceuticals
Locations
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Four Rivers Clinical Research
Paducah, Kentucky, United States
Countries
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Related Links
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Sponsor's website
Other Identifiers
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2007-003638-40
Identifier Type: -
Identifier Source: secondary_id
XTL B07-002
Identifier Type: -
Identifier Source: org_study_id