Conditions

Diabetic Neuropathy, Painful

Keywords

Diabetic Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score
24-hour average pain severity scores were recorded daily by the participant on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The weekly mean was calculated. A negative change indicated an improvement in participant's condition. Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
Baseline, 12 weeks

Secondary Outcomes (9)

Mean Change From Baseline at 12-Week Endpoint in Weekly Mean of Night Pain and Worst Pain
Baseline, 12 weeks
Mean Change From Baseline at 12-Week Endpoint in the BPI-Severity Scale
Baseline, 12 weeks
Mean Change From Baseline at 12-Week Endpoint in the CGI-S Scale
Baseline, 12 weeks
Patient Global Impression of Improvement (PGI-I) Scale at 12-Week Endpoint
12 weeks
Mean Change From Baseline at 12-Week Endpoint in the Sensory Subscale of the SF-MPQ
Baseline, 12 weeks
+4 more secondary outcomes

Study Arms (2)

Duloxetine

EXPERIMENTAL

Drug: Duloxetine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

DuloxetineDRUG

30 mg administered orally (po), QD for 1 week; 60 mg administered po, QD for remaining 11 weeks; 30 mg administered po, QD for 1 week during taper period

Also known as: Cymbalta, LY248686

Duloxetine

PlaceboDRUG

Administered po, QD for 12 weeks; administered po, QD for 1 week during taper period

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Present with pain due to bilateral peripheral neuropathy
Participants must have pain caused by Type 1 or Type 2 diabetes mellitus
Pain must begin in the feet with relatively symmetrical onset
Daily pain should be present for at least 6 months
Diagnosis must be confirmed by a score of at least 3 on the Michigan Neuropathy Screening Inventory (MNSI)
Females must test negative for a serum pregnancy test at Screening. Females of child-bearing potential (who are not surgically sterilized and between menarche and 1 year postmenopause) must agree to use a medically acceptable and reliable means of birth control, during the study and for 1 month following the last study dose.
Stable glycemic control as assessed by a physician investigator and a glycosylated hemoglobin (HbA1c) \<12% before randomization
Score of greater than or equal to 4 on the Brief Pain Inventory (BPI) 24-hour average pain item at Screening.
Full completion of the daily diaries for at least 80% of the days between the second and third time you come to the hospital (Screening).

You may not qualify if:

Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Current (less than or equal to 1 year) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I diagnosis of major depressive disorder, dysthymia, anxiety disorders (excluding phobias), alcohol or eating disorders as determined by the Mini-International Neuropsychiatric Interview (MINI) or a previous diagnosis
DSM-IV diagnosis of mania, bipolar disorder, or psychosis determined either by participant history or by diagnosis using specific MNSI modules
Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychological conditions that in the opinion of investigator would compromise participation or be likely to lead to hospitalization during the course of the study.
At Screening alanine transaminase (ALT) greater than 2 times upper limit of normal (ULN), based on central laboratory reference ranges times ULN, based on central laboratory reference ranges
Prior renal transplant, current renal dialysis, or serum creatinine laboratory value \>1.5 times ULN, based on central laboratory reference ranges at Screening.
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
Pain that cannot be clearly differentiated from or conditions that interfere with the assessment of the diabetic neuropathy pain. Examples of painful conditions that could be confused with diabetic neuropathy pain include peripheral vascular disease, neurological disorders unrelated to diabetic neuropathy, skin condition in the area of the neuropathy that could alter sensation, other painful conditions
Participants who have previously completed or withdrawn from this study or have been previously treated with duloxetine, including participants who participated in study F1J-MC-HMEQ (NCT00408993), even those in the placebo arm
Participants taking excluded medications that cannot be stopped at Screening
Treatment with a monoamine oxidase inhibitor (MAOI) or fluoxetine within 30 days of the third Screening
Participants with a positive Hepatitis B surface antigen and/or Hepatitis C antibody are to be excluded if they have any of the following:
Hepatic dysfunction as determined by the investigator or
Clinical manifestations of liver disease within the previous year such as unexplained pruritus, unexplained dark urine, jaundice, unexplained right upper quadrant tenderness, unexplained "flu-like" symptoms or
Aspartate transaminase (AST), ALT, or bilirubin above the normal reference range.

Contact the study team to confirm eligibility.