Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
128 participants
INTERVENTIONAL
2011-11-30
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DA-9801 300mg
DA-9801 300mg
300mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
DA-9801 600mg
DA-9801 600mg
600mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
DA-9801 900mg
DA-9801 900mg
900mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
Placebo
Placebo
Placebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
Interventions
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DA-9801 300mg
300mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
DA-9801 600mg
600mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
DA-9801 900mg
900mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
Placebo
Placebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
70 Years
ALL
No
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Bongyeon Cha, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea
Hyeok Sang Gwon, M.D.
Role: PRINCIPAL_INVESTIGATOR
Catholic University Yeouido St. Mary's Hopspital
Inkyung Jeong, M.D.
Role: PRINCIPAL_INVESTIGATOR
Gangdong Kyunghee University Hospital
Ji Hyeon Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
Daegu Catholic University Medical Center
Jeong Guk Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Kyungpook National University Hospital
In Ju Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Busan National University Hospital
Young Min Cho, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Chun Hee Jung, M.D.
Role: PRINCIPAL_INVESTIGATOR
Yonsei University Wonju Christian Hospital
Jyeong Hyeon Park, M.D.
Role: PRINCIPAL_INVESTIGATOR
Inje University
Mun Seok Nam, M.D.
Role: PRINCIPAL_INVESTIGATOR
Inha University Hospital
Dong Hyeok Cho, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chonnam National University Hospital
Min Kyong Moon, M.D.
Role: PRINCIPAL_INVESTIGATOR
SMG-SNU Boramae Medical Center
Chong Hwa Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sejong General Hospital
Kwan Pyo Ko, M.D.
Role: PRINCIPAL_INVESTIGATOR
Jeju National University Hospital
Locations
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Chonbuk National University Hospital
Jeonju, , South Korea
Countries
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Other Identifiers
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DA9801_DN_II
Identifier Type: -
Identifier Source: org_study_id
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