Diabetes Mellitus, Type 2, Neuropathic Pain
Conditions
Keywords
pregabalin sustained release tablet
Brief summary
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.
Interventions
DRUGpregabalin sustained release tablet
pregabalin sustained release tablet 150mg qd for 8weeks
DRUGpregabalin immediate release capsule
pregabalin immediate release capsule 75mg bid for 8weeks
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Aged ≥ 19 years, \< 75 years 2. VAS score for diabetic peripheral neuropathy pain ≥ 30 3. Patients who have been administering pregabalin immediate release capsule 150 mg/day for more than 4 weeks 4. Type II DM patient and HbA1c ≤ 10 % 5. Written informed consent
Exclusion criteria
1. Patient with hypersensitivity to pregabalin 2. Patient on anti-epileptic drugs 3. Patients with pain caused by other factors than diabetic peripheral neuropathy 4. Patients undergoing eGFR \<30 mL/min/1.73 m2 (MDRD) at screening 5. AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease 6. Drug-abusing patient 7. Severe depression or uncontrolled abnormal mood and behavioral changes 8. Pregnant and breast-feeding woman 9. Patients who participated in other clinical trials for investigational products within 30 days of screening 10. Patients deemed to be ineligible to participate in the trial by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to week 8 in Visual Analogue Scale(VAS) | Baseline/Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to week 8 in Patients Global Impression of Change(PGIC) | Baseline/Week 8 |
| Change from baseline to week 8 in Clinician Global Impression of Change(CGIC) | Baseline/Week 8 |
| Change from baseline to week 8 in Daily Sleep Interference Scale(DSIS) | Baseline/Week 8 |
| Change from baseline to week 8 in Quality of Life(EQ-5D) | Baseline/Week 8 |
| Dose and frequency of Rescue medication(Acetaminophen) | Baseline/Week 8 |
| Number and proportion of subjects with adverse event | Baseline/Week 8 |
| Change from baseline to week 8 in Morisky Medication Adherence Scale 8-item version(MMAS-8) | Baseline/Week 8 |
Countries
South Korea
Outcome results
None listed