Diabetic Neuropathy Clinical Trial
Official title:
A Phase II Randomized, Double-Blind, Parallel Group, Dose-Ranging, Placebo-Controlled Study to Assess the Safety And Effectiveness Of DA-9801 in the Treatment of Subjects With Diabetic Neuropathy
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.
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.
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