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

NCT01863810 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2013-05-29

No results posted yet for this study

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.

Conditions

  • Diabetic Neuropathy

Interventions

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.

Sponsors & Collaborators

  • KunWha Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kwang-Kuk Kim, M.D., Ph.D. · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01863810 on ClinicalTrials.gov