A Study for Treatment of Pain in Patients With Diabetic Neuropathy.

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test whether a new treatment will be safe and effective in treating pain. Patients with diabetic peripheral neuropathy will be included.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Pregabalin

Criteria

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 glycated hemoglobin (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 known 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 Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria, as determined by the investigator and confirmed by the Mini-International Neuropsychiatric Interview (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.