Diabetic patients with peripheral diabetic neuropathy with typical pain, paraesthesia, allodynia etc.
Inclusion Criteria:
Mean Daily Average DPN pain score of at least 4 on an 11-point scale in the baseline period
Experienced DPN pain on a daily basis for the last 3 months
Have symptoms of DPN for at least 6 months prior to the study entry (this should be confirmed by the history and findings on the neurological examination
Patient is willing to discontinue treatment for chronic pain and other prohibited medications
Have a stable diabetic treatment regimen for the last 3 months prior to screening
Documented daily average DPN assessments for at least 5 days in the baseline period (daily calls for the duration of the study)
Exclusion Criteria:
There are 33 exclusions which are the standard ones for most of the studies, with some additions:
Currently taking Coumadin
History of chronic pain (e.g. joint osteoarthritis or lo back pain) that is more severe than DPN
Patients compensated $50 for the short visits (5 days) or $100 for the long visits (4 days)
Migraine Study (completed)
Duration of the study approximately 8 months (13 clinical visits included in this duration)
Patients compensated $50 for each visit
Inclusion:
at least three migraine headache attacks per month
at least four migraine headache days per month but less than 15 total headache days per month
A history of migraine headaches for at least one year
Age of onset of migraine headaches prior to 50 years
Exclusion:
A history of opioid use for more than 10 days per month
A history of simple analgesic use for more than 15 days per month
A history of seizure disorder(s)
A history of cluster headaches or basilar, ophthalmoplegic, hemiplegic, or transformed migraine headaches
Gout Study (completed)
Patients between the ages of 18-75 years old
Trial length approximately 13 weeks with an option to extend to 6 months
Male or female subjects with post-menopause or surgical sterility, who are all hyperuricemic
Patients compensated $50.00 and more per clinical visit
8100 Yonge Street, Unit #3
Thornhill, Ontario
L4J 6W6
Canada
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