Diabetic Neuropathy
Conditions
Keywords
Diabetic Neuropathy, Neuropathic Pain, Pregabalin
Brief summary
Diabetic neuropathy is known to be the most common complication of diabetes, although the estimated prevalence is highly variable, ranging from 1.6 to 90%. Also, chronic pain is accompanied with sleep disorders, depression, and anxiety, thereby impairing quality of life and increasing societal costs. Pregabalin is one of proven and marketed oral medicine to manage the chronic neuropathic pain in diabetic patients. This study is designed as a randomized controlled trial to demonstrate that the efficacy of KW21052 in pain reduction measured by the weekly mean pain score on the numerical pain rating scale (NRS) at the 8th week of intervention is inferior to that of Lyrica.
Detailed description
Patient Reported Outcomes (PRO) using validated questionnaires and patient diaries will be assessed for efficacy analysis.
Interventions
DRUGKW21052
1 Tablet contains 300mg of pregabalin. Oral, once a day, for 8 weeks.
DRUGLyrica
1 Capsule contains 150mg of pregabalin. Oral, twice a day, for 8 weeks.
DRUGLyrica (low dose)
1 Capsule contains 75mg of pregabalin. Oral, twice a day, for 1 week.
DRUGPlacebo of KW21052
Oral,once a day, for 8 weeks
DRUGPlacebo of Lyrica
Oral, twice a day, for 8 weeks.
Sponsors
KunWha Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 and 2 diabetic patients * Patients diagnosed with diabetic, distal, symmetrical, and sensorimotor polyneuropathy * 40mm and more on VAS * 4 and more on NRS * Informed consented patients
Exclusion criteria
* Participating in another clinical trial * Pregnancy or lactating * Sensitivity to pregabalin * Significant underlying disease or disorders * Prohibited concomitant medications * Significant laboratory abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numerical pain rating scale (NRS) | After 8 weeks of intervention |
Secondary
| Measure | Time frame |
|---|---|
| Response rate | From baseline to 4th and 8th week of intervention |
| Clinical Global Impression of Change (CGIC) | After 8 weeks of intervention |
| Change on on the numerical pain rating scale (NRS) | From baseline to 8th week of intervention |
| Drug compliance | During 8 weeks of intervention |
| Adverse events | Every clinic visit |
| Improved quality of life (QoL) | After 4 and 8 weeks of intervention |
Countries
South Korea
Contacts
Primary ContactHae-kwan Eo
Backup ContactYoungrang Lee
Outcome results
None listed