- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01813799
Study of DA-9801 to Treat Diabetic Neuropathic Pain
April 14, 2019 updated by: Dong-A ST Co., Ltd.
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jeonju, Korea, Republic of, 561-712
- Chonbuk National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Placebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
|
EXPERIMENTAL: 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.
|
EXPERIMENTAL: 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.
|
EXPERIMENTAL: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in average 24-h pain intensity (Likert scale) between before and after IP administration
Time Frame: 8 weeks
|
Subject records the average pain intensity for the past 24 hours in the patient diary at the same time every morning.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inter-group difference in average 24-h pain intensity (Likert scale)
Time Frame: 8 weeks
|
The mean value of the last one week since the date of visit was calculated to compare the difference between treatment groups.
|
8 weeks
|
Most severe mean pain intensity (Likert Scale)
Time Frame: 4, 8 weeks
|
Subject records the most severe pain intensity for the past 24 hours in the patient diary at the same time every morning.
|
4, 8 weeks
|
Overnight pain intensity (Likert Scale)
Time Frame: 4, 8 weeks
|
Subject records the overnight pain intensity during the previous night in the patient diary at the same time every morning.
|
4, 8 weeks
|
Patient's Global Impression of improvement (1 point ~ 7 point)
Time Frame: 4, 8 weeks
|
Subject evaluated the level of symptom improvement during the visits after IP administration.
|
4, 8 weeks
|
Clinical Global Impression of severity (1 point ~ 7 point)
Time Frame: 4, 8 weeks
|
Investigator evaluated the level of symptom severity when a subject visited the institution.
|
4, 8 weeks
|
Average daily dose of acetaminophen
Time Frame: everyday(-2 weeks~0), everyday(0~8 weeks)
|
Subject records dose of acetaminophen during the past 24 hours in patient diary at the same time every
|
everyday(-2 weeks~0), everyday(0~8 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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 Hospital
- Principal Investigator: Kwan Pyo Ko, M.D., Jeju National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2011
Primary Completion (ACTUAL)
July 1, 2013
Study Completion (ACTUAL)
July 1, 2013
Study Registration Dates
First Submitted
March 13, 2013
First Submitted That Met QC Criteria
March 15, 2013
First Posted (ESTIMATE)
March 19, 2013
Study Record Updates
Last Update Posted (ACTUAL)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 14, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA9801_DN_II
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Neuropathies
-
AstraZenecaCompletedDiabetic Neuropathy, Painful; Diabetic NeuropathiesUnited States
-
WinSanTor, IncCompletedPeripheral Neuropathy | Painful Diabetic Neuropathy | Diabetic Neuropathies, PainfulCanada
-
Maastricht University Medical CenterCompletedPainful Diabetic Neuropathy | Diabetic Neuropathies, Painful | Neuralgia, DiabeticNetherlands
-
Helixmith Co., Ltd.CompletedPainful Diabetic NeuropathiesUnited States, Korea, Republic of
-
Imperial College LondonActegy Ltd.Not yet recruitingDiabetic Neuropathies | Diabetic Peripheral Neuropathy | Diabetic Polyneuropathy | Diabetic ComplicationUnited Kingdom
-
Corporacion Parc TauliCompletedDiabetic Neuropathy | Diabetic Nerve Problems | Diabetic Complications NeurologicalPakistan
-
University Medical Centre LjubljanaUnknown
-
Timothy J. Best Medicine Professional CorporationThe Physicians' Services Incorporated FoundationCompleted
-
AbbVie (prior sponsor, Abbott)CompletedDiabetic Neuropathies | Diabetic Neuropathy, Painful | Diabetic Polyneuropathy | Diabetic Neuralgia | Neuralgia, DiabeticUnited States, Canada, France, Germany, Italy, Mexico, Puerto Rico
-
Eva PharmaMARC-CRORecruiting
Clinical Trials on DA-9801 300mg
-
NeuroBo Pharmaceuticals Inc.Dong-A ST Co., Ltd.Completed
-
Georgetown UniversityNational Cancer Institute (NCI); National Human Genome Research Institute (NHGRI)CompletedBreast Cancer | Ovarian CancerUnited States
-
Dong-A ST Co., Ltd.Completed
-
Dong-A ST Co., Ltd.Not yet recruiting
-
Dong-A ST Co., Ltd.RecruitingHepatitis BKorea, Republic of
-
Dong-A ST Co., Ltd.Completed
-
Dong-A ST Co., Ltd.CompletedHealthyKorea, Republic of
-
Myung-gui ChoiDong-A Pharmaceutical Co., Ltd.CompletedHealthy VolunteersKorea, Republic of
-
Dong-A ST Co., Ltd.Not yet recruitingFunctional DyspepsiaKorea, Republic of
-
Dong-A ST Co., Ltd.Recruiting