A Multicenter, Placebo-controlled, Randomized, Double-blind, Phase II Clinical Trial With Diabetic Neuropathy Patients is Designed to Evaluate the Safety and Efficacy of the DA-9801 Tablet for Neuropathic Pain and to Decide Optimal Dose.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Difference in average 24-h pain intensity (Likert scale) between before and after IP administration
Study Overview
Brief Summary
This is a Phase II dose-ranging study to evaluate the effectiveness and safety of DA-9801 in the treatment of pain associated with diabetic neuropathy. Subjects will receive either 300mg, 600mg, 900mg or placebo, three times daily for eight weeks. During treatment, pain score by Likert numerical rating scale, Patient Global Impression of Improvement (PGI-I) and Change in Clinical Global Impression(CGI)are accessed to evaluate the effectiveness.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •the age of 20 ~ 70
- •Type I or Type II Diabetes
- •HbA1c ≤11%
- •Patients with diabetic neuropathic pain for at least 3 months
- •Patients corresponding to average pain level of 4 points or more for 24 hours evaluated with 11-point Likert scale
Exclusion Criteria
- •neuropathic pain due to other causes or another stronger pain other than neuropathic pain
- •abnormal in blood pressure, weight, ALT/AST, Serum creatinine
- •positive reaction in HIV, HBV, or HCV
- •experience of suicide try or Mental Illness Medical History
- •BDI(Beck Depression Inventory) grade exceeding 21 points chronic alcohol abuse history
Arms & Interventions
DA-9801 300mg
Intervention: DA-9801 300mg (Drug)
DA-9801 600mg
Intervention: DA-9801 600mg (Drug)
DA-9801 900mg
Intervention: DA-9801 900mg (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Difference in average 24-h pain intensity (Likert scale) between before and after IP administration
Time Frame: 8 weeks
Subject records the average pain intensity for the past 24 hours in the patient diary at the same time every morning.
Secondary Outcomes
- Average daily dose of acetaminophen(everyday(-2 weeks~0), everyday(0~8 weeks))
- Inter-group difference in average 24-h pain intensity (Likert scale)(8 weeks)
- Most severe mean pain intensity (Likert Scale)(4, 8 weeks)
- Overnight pain intensity (Likert Scale)(4, 8 weeks)
- Patient's Global Impression of improvement (1 point ~ 7 point)(4, 8 weeks)
- Clinical Global Impression of severity (1 point ~ 7 point)(4, 8 weeks)