Study of DA-9801 to Treat Diabetic Neuropathy
Condition: Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This is a double-blind, randomized, parallel group, dose ranging, placebo-controlled study
      where eligible subjects (age 18 to 75 years) will have an average pain score ≥ 4 on an
      11-point Likert numerical rating scale (NRS) for at least four days each week prior to
      randomization as assessed by daily pain diaries. Eligible subjects will be randomized to a
      1:1:1:1 ratio to receive 300mg, 600mg, 900mg of DA-9801, or placebo three times a day for 12
      weeks. During and at the end of the 12-week treatment period subjects will be evaluated for
      safety and efficacy parameters. A follow-up visit for safety will occur two weeks after the
      last treatment visit (TV).

      The Screening Phase (2 weeks) is designed to determine whether subjects are eligible to
      proceed to the Treatment Phase of the study and consists of a series of screening assessments
      designed to determine eligibility. Eligible subjects will undergo a two-week washout period
      for medications and therapies administered for pain management.

      At or up to 21 days before the Screening Visit, written informed consent from (ICF) the
      subject will be obtained by the Investigator or a suitably qualified designee before the
      performance of any protocol specific procedure. At the Screening Visit, the subject will be
      issued a daily diary in order to record daily pain level during the screening phase.

      The Treatment Phase (TV0 to TV12) begins with a series of assessments designed to confirm the
      subjects' continued eligibility. The site will collect the daily diary and the subject's pain
      score will be determined. Only subjects whose average pain score is ≥ 4 for at least four
      days each week will be randomized to any of the four treatment groups.

      DA-9801 administration schedule is three times per day, starting from TV0 to TV12.

      During this study phase subjects will be evaluated on a weekly basis. Efficacy evaluations
      each week will include the subject's global impression of improvement and CGI of pain. Safety
      evaluations during the Treatment Phase will consist of adverse event assessments at each
      visit.

      The Follow-up Visit (two weeks after last TV) The Follow-up Visit is designed to assess
      safety and will occur 14 days after the last TV. If the subject is withdrawn from the study
      prior to TV12, the subject should be exited from the study AFTER completing the specified
      assessments for that visit.
    

Intervention name(s): DA-9801 300mg; DA-9801 600mg; DA-9801 900mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; Pain; Neuropathy