| Criteria: |
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Inclusion Criteria:
- Have pain due to peripheral neuropathy based on disease diagnostic criteria: must
have Type 1 or Type 2 diabetes mellitus, pain must being in the feet, with relatively
symmetrical onset, daily pain must be present for at least 6 months, and diagnosis
must be confirmed by a score of at least 3 on Part B of the Michigan Neuropathy
Screening Instrument.
- Have stable glycemic control, and HbA1c less than or equal to 10%
- Mean score of at least 4 on the 24-hour average page severity assessment from (from
daily diary) Visits 2 to 3.
- Fully completed daily diaries for at least 70% of the days between Visit 2 and 3.
- Women must test negative for a serum pregnancy test at Visit 1, and must agree to use
medically acceptable and reliable means of birth control as determined by the
investigator during the study and for 1 month following the last dose of study drug.
- Are competent and able to freely give own informed consent.
- Have an educational level and degree of understanding such that they can communicate
intelligible with the investigator and study coordinator.
- Have been judged to be reliable and agree to keep all appointments for clinic visits,
tests, and procedures required by the protocol.
Exclusion Criteria:
- Have historical exposure to drugs know to cause neuropathy, or a history of a medical
condition, including pernicious anemia and hypothyroidism, that could have been
responsible for neuropathy.
- Have pain that cannot be clearly differentiated from or conditions that interfere
with the assessment of diabetic neuropathy pain.
- Have had treatment with any centrally active neuroleptic drug within 30 days of visit
3.
- Have had intolerance to pregabalin or have frequent and/or severe allergic reactions
with multiple medications.
- Have current or previous (within the past 1 year) Axis 1 diagnosis of major
depressive disorder, mania, bipolar disorder, psychosis, dysthymia, generalized
anxiety disorder, alcohol or eating disorders according to DSM-IV criteria, as
determined by the investigator and confirmed by the MINI.
- Have a serious of unstable cardiovascular, hepatic, renal, respiratory,
ophthalmologic, gastrointestinal, or hematologic illness, symptomatic peripheral
vascular disease, or other medical condition that in the opinion of the investigator
would compromise participation or be likely to lead to hospitalization during the
course of the study.
- Have alanine aminotransaminase > 2 times upper limit of normal at Visit 1, based on
reference ranges of central lab.
- Have prior renal transplant, current renal dialysis, or serum creatinine laboratory
values > 1.5 times upper limit of normal, based on reference ranges of the central
lab at Visit 1.
- Have a diagnosis or history of glaucoma.
- Are taking excluded medication that cannot be stopped and washed out prior to Visit
2.
- Have history of substance abuse or dependence within the past year, excluding
nicotine and caffeine.
- Are judged clinically by the investigator to be at suicidal risk in the opinion of
the investigator based upon clinical interview and the Columbia Suicide-Severity
Rating Scale.
- Have a positive urine drug screen for any substance of abuse or excluded medication.
- Are unwilling or unable to comply with the use of a data collection device to
directly record data from the subject (daily diary).
- Are pregnant or breast-feeding.
- Are investigator site personnel directly affiliated with this study and/or their
immediate families.
- Are Lilly employees.
- Have received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication at the time of study entry.
- Have a history of recurrent seizures other than febrile seizures.
- Have a history of severe gastroparesis. |