CompletedPhase 2

Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

United States452 participantsStarted 2011-11-28

Plain-language summary

The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age \> 18 years of age
✓. Able to give informed consent and willing to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
✓. Type 1 or type 2 diabetes with a hemoglobin A1c (HbA1c) ≤ 10% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to Screening (insulin therapy is acceptable)
✓. Painful distal symmetrical sensorimotor polyneuropathy (as per American Society of Pain Educators guidelines ) diagnosed for at least 6 months, based on neurological history and/or examination; diagnosis includes absent or reduced deep tendon reflexes at both ankles
✓. At Screening, a pain score of ≥ 40 mm on the SF-MPQ VAS
✓. At Randomization, a pain score of ≥ 40 mm on the SF-MPQ VAS and an ADPS of ≥ 4 on the 11-point NRS, the latter calculated from a minimum of 4 pain ratings in daily diaries obtained during the 1-week Baseline Period (prior to randomization)
✓. Creatinine clearance \> 60 mL/min (estimated using the Cockcroft-Gault equation)
✓. Antidiabetic and other medications anticipated to remain stable and constant during the study period

Exclusion criteria

✕. Diagnosis of mononeuropathy
✕. Use of concomitant medications that may confound assessments of efficacy and/or safety (see Section 5.2)
✕. Major psychiatric disorders
✕. Have had a malignancy other than basal cell carcinoma within the past 2 years
✕. At Visit 1, have a white blood cell count \< 2500/mm3, neutrophil count \< 1500/mm3, or platelet count \< 100 x 103/mm3
✕. Clinically significant unstable diabetes mellitus, unstable hepatic, respiratory, or hematologic illness, unstable cardiovascular disease (including myocardial infarction in the 3 months prior to Visit 1), or symptomatic peripheral vascular disease
✕. Clinically significant findings on the Screening ECG
✕. History of pernicious anemia, untreated hypothyroidism, chronic hepatitis B, hepatitis B within the past 3 months, or human immunodeficiency virus infection

What they're measuring

Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo

Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow up

Trial details

NCT IDNCT01496365

SponsorDaiichi Sankyo

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-09-07

Results submitted2020-11-03

View on ClinicalTrials.gov More Diabetic Peripheral Neuropathy trials