This study is to compare the efficacy and safety of pregabalin sustained release tablet and pregabalin immediate release capsule in type II diabetic patients with peripheral neuropathic pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
pregabalin sustained release tablet 150mg qd for 8weeks
pregabalin immediate release capsule 75mg bid for 8weeks
Dankook University Hospital
Cheonan, Chungcheongnam-do, South Korea
Catholic University of Korea's Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Inje University Haeundae Paik Hospital
Change from baseline to week 8 in Visual Analogue Scale(VAS)
Time frame: Baseline/Week 8
Change from baseline to week 8 in Quality of Life(EQ-5D)
Time frame: Baseline/Week 8
Change from baseline to week 8 in Patients Global Impression of Change(PGIC)
Time frame: Baseline/Week 8
Change from baseline to week 8 in Clinician Global Impression of Change(CGIC)
Time frame: Baseline/Week 8
Change from baseline to week 8 in Daily Sleep Interference Scale(DSIS)
Time frame: Baseline/Week 8
Change from baseline to week 8 in Morisky Medication Adherence Scale 8-item version(MMAS-8)
Time frame: Baseline/Week 8
Dose and frequency of Rescue medication(Acetaminophen)
Time frame: Baseline/Week 8
Number and proportion of subjects with adverse event
Time frame: Baseline/Week 8
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Busan, South Korea
Kosin University Gospel Hospital
Busan, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Daejeon Eulji Medical Center, Eulji University
Daejeon, South Korea
Chungnam National University Sejong Hospital
Sejong, South Korea