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

This study is not yet open for participant recruitment.
Verified May 2013 by KunWha Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
KunWha Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01863810
First received: May 23, 2013
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Diabetic Neuropathy
Drug: KW21052
Drug: Lyrica
Drug: Lyrica (low dose)
Drug: Placebo of KW21052
Drug: Placebo of Lyrica
Phase 3

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

Resource links provided by NLM:


Further study details as provided by KunWha Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Numerical pain rating scale (NRS) [ Time Frame: After 8 weeks of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change on on the numerical pain rating scale (NRS) [ Time Frame: From baseline to 8th week of intervention ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: From baseline to 4th and 8th week of intervention ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Change (CGIC) [ Time Frame: After 8 weeks of intervention ] [ Designated as safety issue: No ]
  • Improved quality of life (QoL) [ Time Frame: After 4 and 8 weeks of intervention ] [ Designated as safety issue: No ]
  • Drug compliance [ Time Frame: During 8 weeks of intervention ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Every clinic visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 394
Study Start Date: August 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01863810

Contacts
Contact: Hae-kwan Eo 82 2 2047 7789 hkeo@kunwha.com
Contact: Youngrang Lee 82 70 4335 4759 yrlee@symyoo.com

Locations
Korea, Republic of
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Kwang-Kuk Kim, M.D., Ph.D.       kkkim@amc.seoul.kr   
Sponsors and Collaborators
KunWha Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Kwang-Kuk Kim, M.D., Ph.D. Asan Medical Center
  More Information

No publications provided

Responsible Party: KunWha Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01863810     History of Changes
Other Study ID Numbers: KW21052_P3
Study First Received: May 23, 2013
Last Updated: May 28, 2013
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by KunWha Pharmaceutical Co., Ltd.:
Diabetic Neuropathy
Neuropathic Pain
Pregabalin

Additional relevant MeSH terms:
Diabetic Neuropathies
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 17, 2014