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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Neuropathy
• Intervention / Treatment: Drug: KW21052; Drug: Lyrica (low dose); Drug: Placebo of Lyrica; Drug: Lyrica; Drug: Placebo of KW21052

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 394
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: KW21052; 1 Tablet contains 300mg of pregabalin. Oral, once 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 Lyrica; Oral, twice a day, for 8 weeks.
Active Comparator: 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.	Drug: Lyrica (low dose); 1 Capsule contains 75mg of pregabalin. Oral, twice a day, for 1 week.; Drug: Lyrica; 1 Capsule contains 150mg of pregabalin. Oral, twice a day, for 8 weeks.; Drug: Placebo of KW21052; Oral,once a day, for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Numerical pain rating scale (NRS)	After 8 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: KunWha Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Kwang-Kuk Kim, M.D., Ph.D., Asan Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): October 1, 2014
• Study Completion (Anticipated): October 1, 2014

Study Registration Dates

• First Submitted: May 23, 2013
• First Submitted That Met QC Criteria: May 28, 2013
• First Posted (Estimate): May 29, 2013

Study Record Updates

• Last Update Posted (Estimate): May 29, 2013
• Last Update Submitted That Met QC Criteria: May 28, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Pregabalin; Neuropathic Pain; Diabetic Neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Diabetic Neuropathies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: KW21052_P3