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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

273

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2008

Geographic Reach

3 countries

13 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

Study Start

First participant enrolled

November 1, 2008

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed

2 years until next milestone

Results Posted

Study results publicly available

May 31, 2012

Completed

Last Updated

May 31, 2012

Status Verified

April 1, 2012

Enrollment Period

1.5 years

First QC Date

November 3, 2008

Results QC Date

August 25, 2011

Last Update Submit

April 30, 2012

Conditions

Diabetic Neuropathy, Painful

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks
This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
Baseline, 5 weeks

Secondary Outcomes (25)

Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks
Baseline, 5 weeks
Change From Baseline in Weekly Mean Worst Daily Pain Severity Score at 5 Weeks
Baseline, 5 weeks
Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score
Baseline through 5 weeks
Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks
Baseline, 5 weeks
Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks
Baseline, 5 weeks
+20 more secondary outcomes

Study Arms (5)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Pregabalin

ACTIVE COMPARATOR

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

Drug: Pregabalin

LY545694 21 mg

EXPERIMENTAL

LY545694 21 milligrams (mg) BID po for 1 week Pregabalin placebo TID po for 6 weeks

Drug: LY545694 21 mg

LY545694 49 mg

EXPERIMENTAL

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

Drug: LY545694 49 mg

LY545694 105 mg

EXPERIMENTAL

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

Drug: LY545694 105 mg

Interventions

PlaceboDRUG

LY545694 placebo BID po for 5 weeks Pregabalin placebo capsules TID po for 6 weeks

Placebo

PregabalinDRUG

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

Pregabalin

LY545694 21 mgDRUG

LY545694 21 mg BID po for 1 week Pregabalin placebo TID po for 6 weeks

Also known as: LY545694

LY545694 21 mg

LY545694 49 mgDRUG

LY545694 escalated to 49 mg BID po for 1 week during Week 2. Pregabalin placebo TID po for 6 weeks.

Also known as: LY545694

LY545694 49 mg

LY545694 105 mgDRUG

LY545694 105 mg BID po for 5 weeks Pregabalin placebo TID po for 6 weeks

Also known as: LY545694

LY545694 105 mg

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
+5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (13)

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, 94904, United States

Location

Tustin, California, 92780, United States

Location

DeLand, Florida, 32720, United States

Location

Fort Myers, Florida, 33912, United States

Location

Jacksonville, Florida, 32216, United States

Location

St Louis, Missouri, 63141, United States

Location

Oklahoma City, Oklahoma, 73109, United States

Location

Dallas, Texas, 75231, United States

Location

Aguascalientes, 20217, Mexico

Location

Mexico City, 11850, Mexico

Location

Monterrey, 64000, Mexico

Location

Hato Rey, 00917, Puerto Rico

Location

Ponce, 00716, Puerto Rico

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Pregabalindasolampanel etibutil

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 3, 2008

First Posted

November 5, 2008

Study Start

November 1, 2008

Primary Completion

May 1, 2010

Study Completion

June 1, 2010

Last Updated

May 31, 2012

Results First Posted

May 31, 2012

Record last verified: 2012-04

Locations

ME(3)PR(2)US(8)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (25)

Study Arms (5)

Placebo

Pregabalin

LY545694 21 mg

LY545694 49 mg

LY545694 105 mg

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations