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

Diabetic Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01863810
• Other study ID #: KW21052_P3
• Status: Not yet recruiting
• Phase: Phase 3
• First received: May 23, 2013
• Last updated: May 28, 2013
• Start date: August 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2013
• Source: KunWha Pharmaceutical Co., Ltd.
• Contact: Hae-kwan Eo
• Phone: 82 2 2047 7789
• Email: hkeo[@]kunwha.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Description:

Patient Reported Outcomes (PRO) using validated questionnaires and patient diaries will be assessed for efficacy analysis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 394
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy
• Neuralgia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
KunWha Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical pain rating scale (NRS)		After 8 weeks of intervention	No
Secondary	Change on on the numerical pain rating scale (NRS)		From baseline to 8th week of intervention	No
Secondary	Response rate		From baseline to 4th and 8th week of intervention	No
Secondary	Clinical Global Impression of Change (CGIC)		After 8 weeks of intervention	No
Secondary	Improved quality of life (QoL)		After 4 and 8 weeks of intervention	No
Secondary	Drug compliance		During 8 weeks of intervention	Yes
Secondary	Adverse events		Every clinic visit	Yes