A Study to Evaluate the Safety of DA-3030 and to Explore the Efficacy for Diabetic Neuropathic Pain
NCT ID: NCT01820715
Last Updated: 2013-08-13
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
PHASE1
31 participants
INTERVENTIONAL
2010-06-30
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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600㎍ of DA-3030 Injection
600㎍ of DA-3030 is injected once a day, for 5 continuous days.
600㎍ of DA-3030 Injection
Placebo
Placebo(a salin drip) is injected once a day, for 5 continuous days.
Placebo
Interventions
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600㎍ of DA-3030 Injection
Placebo
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with 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 mor for 24 hours evaluated with 11-point Likert scale
Exclusion Criteria
* Another stronger pain other than neuropathic pain
* Abnormality in blood pressure, weight
* Positive reaction in HIV, HBV or HCV
* A medical history of mental illness within 6 months
* The grade of BDI(Beck Depression Inventory) exceeds 21 points
* History of drug/alcohol abuse
20 Years
70 Years
ALL
No
Sponsors
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Dong-A Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yoo Heon Ahn, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hanyang University
Bong Yeon Cha, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hospital, The Catholic University of Korea
Kyung Soo Ko, M.D, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Inje University
Tae Sun Park, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chonbuk National University Hospital
Young Soo Park, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hanyang University
Choon Hee Chung, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Wonju Christian Hospital
In Joo Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Hospital
Locations
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Hanyang University Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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DA3030_DN_I (Version 3.4)
Identifier Type: -
Identifier Source: org_study_id