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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by KunWha Pharmaceutical Co., Ltd..
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01863810
First Posted: May 29, 2013
Last Update Posted: May 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
KunWha Pharmaceutical Co., Ltd.
May 23, 2013
May 29, 2013
May 29, 2013
August 2013
October 2014   (Final data collection date for primary outcome measure)
Numerical pain rating scale (NRS) [ Time Frame: After 8 weeks of intervention ]
Same as current
No Changes Posted
  • Change on on the numerical pain rating scale (NRS) [ Time Frame: From baseline to 8th week of intervention ]
  • Response rate [ Time Frame: From baseline to 4th and 8th week of intervention ]
  • Clinical Global Impression of Change (CGIC) [ Time Frame: After 8 weeks of intervention ]
  • Improved quality of life (QoL) [ Time Frame: After 4 and 8 weeks of intervention ]
  • Drug compliance [ Time Frame: During 8 weeks of intervention ]
  • Adverse events [ Time Frame: Every clinic visit ]
Same as current
Not Provided
Not Provided
 
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.
Patient Reported Outcomes (PRO) using validated questionnaires and patient diaries will be assessed for efficacy analysis.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Neuropathy
  • 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.
  • 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.
    Interventions:
    • Drug: KW21052
    • Drug: Lyrica (low dose)
    • Drug: Placebo of Lyrica
  • 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.
    Interventions:
    • Drug: Lyrica
    • Drug: Lyrica (low dose)
    • Drug: Placebo of KW21052
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
394
October 2014
October 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01863810
KW21052_P3
No
Not Provided
Not Provided
KunWha Pharmaceutical Co., Ltd.
KunWha Pharmaceutical Co., Ltd.
Not Provided
Principal Investigator: Kwang-Kuk Kim, M.D., Ph.D. Asan Medical Center
KunWha Pharmaceutical Co., Ltd.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP