NCT01863810

Efficacy and Safety of KW21052 Compared to Lyrica in the Diabetic Patients With Neuropathic Pain

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 394 (estimated)
• Sponsor: KunWha Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	KW21052	1 Tablet contains 300mg of pregabalin. Oral, once a day, for 8 weeks.
DRUG	Lyrica	1 Capsule contains 150mg of pregabalin. Oral, twice a day, for 8 weeks.
DRUG	Lyrica (low dose)	1 Capsule contains 75mg of pregabalin. Oral, twice a day, for 1 week.
DRUG	Placebo of KW21052	Oral,once a day, for 8 weeks
DRUG	Placebo of Lyrica	Oral, twice a day, for 8 weeks.

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-05-29
• Last updated: 2013-05-29

Locations

1 site across 1 country: South Korea