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Completed

NCT Number: NCT01813799

Study of DA-9801 to Treat Diabetic Neuropathic Pain

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.

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Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-9801 300mg

Drug

300mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.

DA-9801 600mg

Drug

600mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.

DA-9801 900mg

Drug

900mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.

Placebo

Drug

Placebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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. 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.

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2013
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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