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Study of DA-9801 to Treat Diabetic Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT01813799
Recruitment Status : Unknown
Verified August 2013 by Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. ).
Recruitment status was:  Recruiting
First Posted : March 19, 2013
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. )

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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Drug: DA-9801 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Clinical Study to Evaluate DA-9801 Tablet's Effectiveness and Safety and to Decide Optimal Volume for Neuropathic Pains With Diabetic Neuropathy Patients as the Target
Study Start Date : November 2011
Estimated Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: DA-9801
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.
Drug: DA-9801
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.
Drug: DA-9801
Placebo Comparator: Placebo
Placebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
Drug: Placebo



Primary Outcome Measures :
  1. Average pain score reduction compared to baseline [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Average pain score [ Time Frame: 8 weeks ]
  2. Most severe pain score [ Time Frame: 8 weeks ]
  3. Overnight pain score [ Time Frame: 8 weeks ]
  4. Patient global impression of improvement [ Time Frame: 8 weeks ]
  5. Clinical global impression [ Time Frame: 8 weeks ]
  6. Average weekly rescue medication use [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813799


Contacts
Contact: Tae Seon Park, M.D., Ph.D. 82-2-63-250-2154 irb@cuh.co.kr

Locations
Korea, Republic of
Chonbuk National University Hospital Recruiting
Jeon-ju, Korea, Republic of, 561-712
Contact: Tae Seon Park, M.D., Ph.D.    82-63-250-1794    pts@chonbuk.ac.kr   
Principal Investigator: Tae Seon Park, M.D., Ph.D.         
Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
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
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

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01813799     History of Changes
Other Study ID Numbers: DA-9801
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

Keywords provided by Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. ):
Diabetic Neuropathies

Additional relevant MeSH terms:
Neuralgia
Diabetic Neuropathies
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases