Clinical trial NCT01813799: Study of DA-9801 to Treat Diabetic Neuropathic Pain
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Neuropathies
Keywords: Diabetic Neuropathies
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-19
Enrollment: 128
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in average 24-h pain intensity (Likert scale) between before and after IP administration
timeFrame: 8 weeks
Secondary outcomes:
measure: Inter-group difference in average 24-h pain intensity (Likert scale)
timeFrame: 8 weeks
measure: Most severe mean pain intensity (Likert Scale)
timeFrame: 4, 8 weeks
measure: Overnight pain intensity (Likert Scale)
timeFrame: 4, 8 weeks
measure: Patient's Global Impression of improvement (1 point ~ 7 point)
timeFrame: 4, 8 weeks
measure: Clinical Global Impression of severity (1 point ~ 7 point)
timeFrame: 4, 8 weeks
measure: Average daily dose of acetaminophen
timeFrame: everyday(-2 weeks~0), everyday(0~8 weeks)
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Bongyeon Cha, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University Yeouido St. Mary's Hopspital
name: Hyeok Sang Gwon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gangdong Kyunghee University Hospital
name: Inkyung Jeong, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Daegu Catholic University Medical Center
name: Ji Hyeon Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook National University Hospital
name: Jeong Guk Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Busan National University Hospital
name: In Ju Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Young Min Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yonsei University Wonju Christian Hospital
name: Chun Hee Jung, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Jyeong Hyeon Park, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital
name: Mun Seok Nam, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Dong Hyeok Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: SMG-SNU Boramae Medical Center
name: Min Kyong Moon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sejong General Hospital
name: Chong Hwa Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jeju National University Hospital
name: Kwan Pyo Ko, M.D.
role: PRINCIPAL_INVESTIGATOR
References: