Study of DA-9801 to Treat Diabetic Neuropathic Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Dong-A ST Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01813799
First received: March 13, 2013
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Diabetic Neuropathies
Drug: DA-9801
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • Average pain score reduction compared to baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average pain score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Most severe pain score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Overnight pain score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Patient global impression of improvement [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Clinical global impression [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Average weekly rescue medication use [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 ST 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. Kyungbook 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
  More Information

No publications provided

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01813799     History of Changes
Other Study ID Numbers: DA-9801
Study First Received: March 13, 2013
Last Updated: August 12, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

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

ClinicalTrials.gov processed this record on September 18, 2014