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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

394 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Diabetic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

KW21052

Intervention Type DRUG

1 Tablet contains 300mg of pregabalin. Oral, once a day, for 8 weeks.

Lyrica (low dose)

Intervention Type DRUG

1 Capsule contains 75mg of pregabalin. Oral, twice a day, for 1 week.

Placebo of Lyrica

Intervention Type DRUG

Oral, twice a day, for 8 weeks.

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.

Group Type ACTIVE_COMPARATOR

Lyrica

Intervention Type DRUG

1 Capsule contains 150mg of pregabalin. Oral, twice a day, for 8 weeks.

Lyrica (low dose)

Intervention Type DRUG

1 Capsule contains 75mg of pregabalin. Oral, twice a day, for 1 week.

Placebo of KW21052

Intervention Type DRUG

Oral,once a day, for 8 weeks

Interventions

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KW21052

1 Tablet contains 300mg of pregabalin. Oral, once a day, for 8 weeks.

Intervention Type DRUG

Lyrica

1 Capsule contains 150mg of pregabalin. Oral, twice a day, for 8 weeks.

Intervention Type DRUG

Lyrica (low dose)

1 Capsule contains 75mg of pregabalin. Oral, twice a day, for 1 week.

Intervention Type DRUG

Placebo of KW21052

Oral,once a day, for 8 weeks

Intervention Type DRUG

Placebo of Lyrica

Oral, twice a day, for 8 weeks.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No