Conditions

Diabetic Neuropathies

Outcome Measures

Primary Outcomes (1)

Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint
Maintenance effect of duloxetine 60 mg in patients with diabetic peripheral neuropathic pain (DPNP) was assessed by the change in BPI 24-hour average pain item score from baseline of the maintenance therapy arm (week 8) to 34 week endpoint in patients who achieved at least a 30 percent reduction on the BPI 24-hour average pain item after 8 weeks of acute therapy (Acute Therapy Phase). BPI is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Baseline (Week 8), Week 34

Secondary Outcomes (40)

Maintenance Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item
Baseline (Week 0), Week 34
Rescue Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item
Baseline (Week 0), Week 34
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint
Baseline (Week 8), Week 34
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint
Baseline (Week 8), Week 34
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint
Baseline (Week 8), Week 34
+35 more secondary outcomes

Study Arms (1)

Duloxetine

EXPERIMENTAL

All subjects receive 30 mg once daily (QD), by mouth (per os - PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months. Patients beginning maintenance at the 60 mg QD dose could be increased to the 120 mg QD level if they did not maintain appropriate level of response throughout the maintenance period.

Drug: Duloxetine

Interventions

DuloxetineDRUG

Also known as: LY248686, Cymbalta

Duloxetine

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months.
May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.
Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.

You may not qualify if:

History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis),kidney, respiratory, or blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or be likely to lead to hospitalization during the course of the study.
Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study.
Treatment with fluoxetine within 30 days of starting the study.
Unstable blood sugar control and uncontrolled or poorly controlled hypertension.

Contact the study team to confirm eligibility.