Status:
COMPLETED
Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Lead Sponsor:
Daiichi Sankyo
Conditions:
Diabetic Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Diabetic peripheral neuropathy (DPN) affects up to 50% of patients who have diabetes for at least 25 years. Up to 26% of all patients with DPN experience neuropathic pain. DPN pain contributes to slee...
Eligibility Criteria
Inclusion
- 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
- Women of child bearing potential (WOCBP) must be using an adequate method of contraception as detailed in the protocol to avoid pregnancy during the study and for 4 weeks after study completion
Exclusion
- 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
- Amputations of body parts other than toes
- Prior therapeutic failure of pregabalin or gabapentin (considered unresponsive or intolerant to treatment); therapeutic failure implies lack of efficacy following full titration to effective doses (eg, 300 mg/day for pregabalin)
- Known hypersensitivity to pregabalin or gabapentin
- Requirement for concomitant anticonvulsant and antidepressant therapy, with the exception of stable doses of SSRIs
- Neurologic disorders unrelated to DPN that may confound the assessment of pain associated with DPN
- Skin conditions that could alter sensation
- Other sources of pain that may confound assessment or self-evaluation of the pain due to DPN
- Abuse of prescription medications, street drugs or alcohol (including alcohol dependence) within the last 1 year
- Current enrollment in another investigational study, participation in another investigational study with the past 30 days, or other current or recent use of any investigational drug
- Pregnancy (as based on lab test results) or breast feeding
- Laboratory values exceeding limits listed in Table 4.1 of the protocol
Key Trial Info
Start Date :
November 28 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2012
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT01496365
Start Date
November 28 2011
End Date
September 7 2012
Last Update
January 5 2021
Active Locations (78)
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Birmingham, Alabama, United States, 35242
2
Huntsville, Alabama, United States, 35801
3
Mesa, Arizona, United States, 85206
4
Phoenix, Arizona, United States, 85023