NCT01179672.

Trial name or title	Treatment of patients with diabetic peripheral neuropathic pain in China: duloxetine versus placebo
Methods	Randomized, double blind (subject, investigator), placebo‐controlled, parallel assignment, efficacy study
Participants	People over 18 years of age who present with pain due to bilateral diabetic peripheral neuropathy (type 1 or type 2 diabetes). Pain beginning in feet, relatively symmetrical onset, present daily for at least 6 months, confirmed by score of ≥ 3 on Michigan Neuropathy Screening Inventory
Interventions	Duloxetine 30 mg orally, once daily for 1 week; 60 mg once daily for next 11 weeks; 30 mg administered orally, once daily for 1 week during taper period Placebo once daily for 12 weeks, once daily for 1 week during taper period
Outcomes	Primary: Mean change in the pain severity score (measured from baseline to 12‐week endpoint) Secondary (changes measured from baseline to 12‐week endpoint): Mean change in night pain and worst pain Mean change in the Brief Pain Inventory (BPI)‐Severity scale Mean change in the Clinical Global Impression ‐ Severity (CGI‐S) scale Patient Global Impression of Improvement (PGI‐I) scale Mean change in the Sensory portion of the Short‐form McGill pain questionnaire Percentage of participants who experience ≥ 30%, ≥ 50% or ≥ 75% reduction from baseline to 12 week endpoint in average daily pain Percentage of participants who experience ≥ 30%, ≥ 50% or ≥ 75% reduction from baseline in BPI‐Severity average pain scores Mean change in the Brief Pain Inventory (BPI) Interference scores Mean change in the Sheehan Disability Scale (SDS)
Starting date	April 2011
Contact information	Eli Lilly and Company. Study director, tel: 1‐877‐CTLILLY (1‐877‐285‐4559) or 1‐317‐615‐4559
Notes	NCT01179672