A Study to Evaluate the Safety of DA-3030 and to Explore the Efficacy for Diabetic Neuropathic Pain

Dong-A Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Diabetic Neuropathy

Treatments: Drug: 600㎍ of DA-3030 Injection; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01820715

DA3030_DN_I (Version 3.4)

Details and patient eligibility

About

A multi-centers, placebo-controlled, randomized, double-blinded, pilot clinical trial is designed to evaluate the safety of the DA-3030 injection and to explore the efficacy for Neuropathic pain.

Enrollment: 31 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 20≤ Age ≤ 70
• Diagnosed with 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 mor for 24 hours evaluated with 11-point Likert scale

Exclusion criteria

• Neuropathic pain due to other causes
• Another stronger pain other than neuropathic pain
• Abnormality in blood pressure, weight
• Positive reaction in HIV, HBV or HCV
• A medical history of mental illness within 6 months
• The grade of BDI(Beck Depression Inventory) exceeds 21 points
• History of drug/alcohol abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

31 participants in 2 patient groups, including a placebo group

600㎍ of DA-3030 Injection

Experimental group

Description:

600㎍ of DA-3030 is injected once a day, for 5 continuous days.

Treatment:

Drug: 600㎍ of DA-3030 Injection

Placebo

Placebo Comparator group

Description:

Placebo(a salin drip) is injected once a day, for 5 continuous days.

Treatment:

Drug: Placebo