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

NCT ID: NCT00785577

Last Updated: 2012-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 273 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-06-30

Brief 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.

Conditions

Diabetic Neuropathy, Painful

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules thrice daily (TID) po for 6 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

LY545694 placebo BID po for 5 weeks

Pregabalin placebo capsules TID po for 6 weeks

Pregabalin

Pregabalin thrice daily (TID) oral for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6

LY545694 placebo BID po for 5 weeks

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: DRUG

Pregabalin TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6

LY545694 placebo BID po for 5 weeks

LY545694 21 mg

LY545694 21 milligrams (mg) BID po for 1 week

Pregabalin placebo TID po for 6 weeks

Group Type: EXPERIMENTAL

LY545694 21 mg

Intervention Type: DRUG

LY545694 21 mg BID po for 1 week

Pregabalin placebo TID po for 6 weeks

LY545694 49 mg

LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.

Pregabalin placebo TID po for 6 weeks

Group Type: EXPERIMENTAL

LY545694 49 mg

Intervention Type: DRUG

LY545694 escalated to 49 mg BID po for 1 week during Week 2.

Pregabalin placebo TID po for 6 weeks.

LY545694 105 mg

LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.

Pregabalin placebo TID po for 6 weeks

Group Type: EXPERIMENTAL

LY545694 105 mg

Intervention Type: DRUG

LY545694 105 mg BID po for 5 weeks

Pregabalin placebo TID po for 6 weeks

Interventions

Placebo

LY545694 placebo BID po for 5 weeks

Pregabalin placebo capsules TID po for 6 weeks

Intervention Type: DRUG

Pregabalin

Pregabalin TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6

LY545694 placebo BID po for 5 weeks

Intervention Type: DRUG

LY545694 21 mg

LY545694 21 mg BID po for 1 week

Pregabalin placebo TID po for 6 weeks

Intervention Type: DRUG

LY545694 49 mg

LY545694 escalated to 49 mg BID po for 1 week during Week 2.

Pregabalin placebo TID po for 6 weeks.

Intervention Type: DRUG

LY545694 105 mg

LY545694 105 mg BID po for 5 weeks

Pregabalin placebo TID po for 6 weeks

Intervention Type: DRUG

Other Intervention Names

LY545694; LY545694; LY545694

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Greenbrae, California, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tustin, California, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

DeLand, Florida, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Fort Myers, Florida, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Jacksonville, Florida, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

St Louis, Missouri, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Oklahoma City, Oklahoma, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Dallas, Texas, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Aguascalientes, , Mexico

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Mexico City, , Mexico

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Monterrey, , Mexico

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hato Rey, , Puerto Rico

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Ponce, , Puerto Rico

Countries

United States; Mexico; Puerto Rico

Other Identifiers

H8C-MC-LQBF

Identifier Type: OTHER

Identifier Source: secondary_id

11977

Identifier Type: -

Identifier Source: org_study_id