Study of DA-9801 to Treat Diabetic Neuropathic Pain
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.
1 other identifier
interventional
128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 13, 2013
CompletedFirst Posted
Study publicly available on registry
March 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedApril 16, 2019
April 1, 2019
1.7 years
March 13, 2013
April 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
8 weeks
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (4)
DA-9801 300mg
EXPERIMENTALDA-9801 600mg
EXPERIMENTALDA-9801 900mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chonbuk National University Hospital
Jeonju, 561-712, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bongyeon Cha, M.D.
The Catholic University of Korea
- PRINCIPAL INVESTIGATOR
Hyeok Sang Gwon, M.D.
Catholic University Yeouido St. Mary's Hopspital
- PRINCIPAL INVESTIGATOR
Inkyung Jeong, M.D.
Gangdong Kyunghee University Hospital
- PRINCIPAL INVESTIGATOR
Ji Hyeon Lee, M.D.
Daegu Catholic University Medical Center
- PRINCIPAL INVESTIGATOR
Jeong Guk Kim, M.D.
Kyungpook National University Hospital
- PRINCIPAL INVESTIGATOR
In Ju Kim, M.D.
Busan National University Hospital
- PRINCIPAL INVESTIGATOR
Young Min Cho, M.D.
Seoul National University Hospital
- PRINCIPAL INVESTIGATOR
Chun Hee Jung, M.D.
Yonsei University Wonju Christian Hospital
- PRINCIPAL INVESTIGATOR
Jyeong Hyeon Park, M.D.
Inje University
- PRINCIPAL INVESTIGATOR
Mun Seok Nam, M.D.
Inha University Hospital
- PRINCIPAL INVESTIGATOR
Dong Hyeok Cho, M.D.
Chonnam National University Hospital
- PRINCIPAL INVESTIGATOR
Min Kyong Moon, M.D.
SMG-SNU Boramae Medical Center
- PRINCIPAL INVESTIGATOR
Chong Hwa Kim, M.D.
Sejong General Hospital
- PRINCIPAL INVESTIGATOR
Kwan Pyo Ko, M.D.
Jeju National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2013
First Posted
March 19, 2013
Study Start
November 1, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
April 16, 2019
Record last verified: 2019-04