Study of DA-9801 to Treat Diabetic Neuropathic Pain

Phase 2

Completed

• Conditions: Diabetic Neuropathies
• Interventions: Drug: DA-9801 300mg; Drug: DA-9801 600mg; Drug: DA-9801 900mg; Drug: Placebo

• Registration Number: NCT01813799
• Lead Sponsor: Dong-A ST 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-15
• Study First Posted: 2013-03-19
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-14
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA-9801 300mg	DA-9801 300mg	-
DA-9801 600mg	DA-9801 600mg	-
DA-9801 900mg	DA-9801 900mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Difference in average 24-h pain intensity (Likert scale) between before and after IP administration	8 weeks	Subject records the average pain intensity for the past 24 hours in the patient diary at the same time every morning.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of