Study of DA-9801 to Treat Diabetic Neuropathy
Condition: Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Intervention: DA-9801 300mg; DA-9801 600mg; DA-9801 900mg; Placebo
Intervention description: 300 mg of DA-9801 in tablet form, 100 mg to be taken 3 times daily for 12 weeks.; 600 mg of DA-9801 in tablet form, 200 mg to be taken 3 times daily for 12 weeks.; 900 mg of DA-9801 in tablet form, to be taken 300 mg to be taken 3 times daily for 12 weeks.; Placebo, in tablet form, to be taken 3 times daily for 12 weeks. The placebo is the same formulation as DA-9801 except that it does not contain the active pharmaceutical ingredient.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetes; Pain; Neuropathy

Summary:

      To evaluate the effectiveness of DA-9801 at 300mg, 600mg, 900mg and placebo, in reducing pain
      in subjects with diabetic neuropathic pain compared to their baseline values.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be 18 to 75 years of age

          -  Diagnosed with Type I or Type II diabetes

          -  HbA1c ≤ 12% at the time of screening

          -  Has diabetic neuropathic pain (numbness, soreness, shooting or poking pain) in the
             lower extremities for more than 3 months prior to screening and with no adequate
             relief from other treatments

          -  Has an average pain score of ≥ 4 for 24 hours at least 4 days out of the week prior to
             randomization as assessed by the 11-point Likert NRS.

          -  If female of childbearing potential, subject must have a negative serum pregnancy test
             at screening

          -  Understands and is willing to participate in the clinical study and can comply with
             study procedures and visits.

          -  Normal cognitive and communicative ability as judged by clinical assessment and
             ability to complete self-reported questionnaires

          -  Subject is willing and able to give informed consent

        Exclusion Criteria:

          -  Evidence of another type of neuropathic pain caused by a condition other than diabetes

          -  Pain from another source as severe or greater than the pain under study

          -  BMI (Body Mass Index) > 37 kg/m2

          -  Clinical signs of infection related to sores of any type on the legs

          -  Subjects on any investigational drug(s) or therapeutic device(s) within 30 days
             preceding screening; or subject or physician anticipates use of any of these therapies
             by the subject during the course of the study

          -  Previous participation in the Treatment Phase of this Protocol

          -  History of drug or alcohol abuse, within the past 6 months

          -  Malignant disease not in remission for 5 years or more that has been medically or
             surgically treated without evidence of metastases

          -  Presence of one or more medical conditions, as determined by medical history, which
             seriously compromises the subject's ability to complete the study, including history
             of poor adherence with medical treatment, renal, hepatic, hematologic, active
             auto-immune or immune diseases that, in the opinion of the Investigator, would make
             the subject an inappropriate candidate for this study: c) One or more abnormal blood
             biochemistry analyte result that is ≥ 3 times that of the upper limit of the normal
             range; d) For laboratory results that are significantly lower than the normal range,
             specific criteria will be used to judge subject eligibility for randomization for
             Total protein, Albumin, and Hemoglobin or Platelets.

          -  Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history
             known to be infected with Human Immunodeficiency Virus (HIV)

          -  New York Heart Association (NYHA) Class III and IV congestive heart failure (CHF), as
             defined by the following criteria: a)Class III: Symptoms with moderate exertion
             b)Class IV: Symptoms at rest

          -  Pregnant or breast feeding

          -  Women of child-bearing potential not using an effective birth control method. Women of
             child-bearing potential are defined as women physiologically capable of becoming
             pregnant, UNLESS they meet the following criteria:

             d) Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of
             spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40mIU/m,
             OR; e) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy, OR;
             f) Are using one or more of the following acceptable methods of contraception:
             surgical sterilization, hormonal contraception, and double-barrier methods. Reliable
             contraception should be maintained throughout the study and for 7 days after study
             discontinuation.

          -  Subjects with a diagnosis of psychiatric disorders such as major depressive disorder,
             bipolar disorder, obsessive compulsive disorder, generalized anxiety, dysthymia or
             suicidality/suicide ideation

          -  Administration of local anesthetic shot or systemic steroids within two months of
             screening

          -  Subjects not willing to undergo a two-week washout period for pharmacologic and
             non-pharmacologic pain management techniques