Study of DA-9801 to Treat Diabetic Neuropathic Pain

Diabetic Neuropathies Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813799
• Other study ID #: DA9801_DN_II
• Status: Completed
• Phase: Phase 2
• Start date: November 2011
• Est. completion date: July 2013

Study information

• Verified date: April 2019
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Neuralgia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Jeonju

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in average 24-h pain intensity (Likert scale) between before and after IP administration	Subject records the average pain intensity for the past 24 hours in the patient diary at the same time every morning.	8 weeks
Secondary	Inter-group difference in average 24-h pain intensity (Likert scale)	The mean value of the last one week since the date of visit was calculated to compare the difference between treatment groups.	8 weeks
Secondary	Most severe mean pain intensity (Likert Scale)	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
Secondary	Overnight pain intensity (Likert Scale)	Subject records the overnight pain intensity during the previous night in the patient diary at the same time every morning.	4, 8 weeks
Secondary	Patient's Global Impression of improvement (1 point ~ 7 point)	Subject evaluated the level of symptom improvement during the visits after IP administration.	4, 8 weeks
Secondary	Clinical Global Impression of severity (1 point ~ 7 point)	Investigator evaluated the level of symptom severity when a subject visited the institution.	4, 8 weeks
Secondary	Average daily dose of acetaminophen	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)