Randomized, Double-blinded, Double-dummy, Active-controlled, Multi-center Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of KW21052 for 8 Weeks Compared to Pregabalin (Lyrica) in the Diabetic Patients With Neuropathic Pain
Overview
- Phase
- Phase 3
- Intervention
- KW21052
- Conditions
- Diabetic Neuropathy
- Sponsor
- KunWha Pharmaceutical Co., Ltd.
- Enrollment
- 394
- Locations
- 1
- Primary Endpoint
- Numerical pain rating scale (NRS)
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
KW21052
This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with KW21052 300mg and Placebo of Lyrica for intervention period of 8 weeks.
Intervention: KW21052
KW21052
This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with KW21052 300mg and Placebo of Lyrica for intervention period of 8 weeks.
Intervention: Lyrica (low dose)
KW21052
This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with KW21052 300mg and Placebo of Lyrica for intervention period of 8 weeks.
Intervention: Placebo of Lyrica
LYRICA
This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with Lyrica 300mg (150mg bid) and Placebo of KW21052 300mg for intervention period of 8 weeks.
Intervention: Lyrica
LYRICA
This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with Lyrica 300mg (150mg bid) and Placebo of KW21052 300mg for intervention period of 8 weeks.
Intervention: Lyrica (low dose)
LYRICA
This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with Lyrica 300mg (150mg bid) and Placebo of KW21052 300mg for intervention period of 8 weeks.
Intervention: Placebo of KW21052
Outcomes
Primary Outcomes
Numerical pain rating scale (NRS)
Time Frame: After 8 weeks of intervention
Secondary Outcomes
- Change on on the numerical pain rating scale (NRS)(From baseline to 8th week of intervention)
- Response rate(From baseline to 4th and 8th week of intervention)
- Clinical Global Impression of Change (CGIC)(After 8 weeks of intervention)
- Improved quality of life (QoL)(After 4 and 8 weeks of intervention)
- Drug compliance(During 8 weeks of intervention)
- Adverse events(Every clinic visit)