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

NCT01863810 | Unknown Phase 3

• 1 other identifier: KW21052_P3
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetic Neuropathy; Neuropathic Pain; Pregabalin

Outcome Measures

Primary Outcomes (1)

• Numerical pain rating scale (NRS)

  After 8 weeks of intervention

Secondary Outcomes (6)

• 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

Study Arms (2)

KW21052

EXPERIMENTAL

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; Drug: Lyrica (low dose); Drug: Placebo of Lyrica

LYRICA

ACTIVE COMPARATOR

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; Drug: Lyrica (low dose); Drug: Placebo of KW21052

Interventions

KW21052 DRUG

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

KW21052

Lyrica DRUG

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

LYRICA

Lyrica (low dose) DRUG

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

KW21052; LYRICA

Placebo of KW21052 DRUG

Oral,once a day, for 8 weeks

LYRICA

Placebo of Lyrica DRUG

Oral, twice a day, for 8 weeks.

KW21052

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 and 2 diabetic patients
• Patients diagnosed with diabetic, distal, symmetrical, and sensorimotor polyneuropathy
• mm and more on VAS
• and more on NRS
• Informed consented patients

You may not qualify if:

• Participating in another clinical trial
• Pregnancy or lactating
• Sensitivity to pregabalin
• Significant underlying disease or disorders
• Prohibited concomitant medications
• Significant laboratory abnormalities

Sponsors & Collaborators

• KunWha Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Neuralgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Kwang-Kuk Kim, M.D., Ph.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hae-kwan Eo

CONTACT

82 2 2047 7789; hkeo@kunwha.com

Youngrang Lee

CONTACT

82 70 4335 4759; yrlee@symyoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: May 29, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

KR (1)