A Phase 2 interventional study of DA-9801 300mg and DA-9801 600mg in Diabetic Neuropathies, sponsored by Dong-A ST Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Dong-A ST Co., Ltd. · Phase 2, Interventional, and Treatment
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.
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's enrollment of 128 is above the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: DA-9801 300mg
Drug: DA-9801 600mg
Drug: DA-9801 900mg
Drug: Placebo
300mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
600mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
900mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
Placebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
Difference in average 24-h pain intensity (Likert scale) between before and after IP administration
Subject records the average pain intensity for the past 24 hours in the patient diary at the same time every morning.
Time frame: 8 weeks
Inter-group difference in average 24-h pain intensity (Likert scale)
The mean value of the last one week since the date of visit was calculated to compare the difference between treatment groups.
Time frame: 8 weeks
Most severe mean pain intensity (Likert Scale)
Subject records the most severe pain intensity for the past 24 hours in the patient diary at the same time every morning.
Time frame: 4, 8 weeks
Overnight pain intensity (Likert Scale)
Subject records the overnight pain intensity during the previous night in the patient diary at the same time every morning.
Time frame: 4, 8 weeks
Patient's Global Impression of improvement (1 point ~ 7 point)
Subject evaluated the level of symptom improvement during the visits after IP administration.
Time frame: 4, 8 weeks
Clinical Global Impression of severity (1 point ~ 7 point)
Investigator evaluated the level of symptom severity when a subject visited the institution.
Time frame: 4, 8 weeks
Average daily dose of acetaminophen
Subject records dose of acetaminophen during the past 24 hours in patient diary at the same time every
Time frame: everyday(-2 weeks~0), everyday(0~8 weeks)
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Dong-A ST Co., Ltd.