Trial | NCT01863810  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    pregabalin ...

  • Study Participants

    394
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.
Study Started
Aug 31
2013
Primary Completion
Oct 31
2014
Anticipated
Study Completion
Oct 31
2014
Anticipated
Last Update
May 29
2013
Estimate

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.

Drug KW21052

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

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.

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.

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
No Results Posted