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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregabalin sustained release tablet | Experimental | pregabalin sustained release tablet 150mg qd for 8weeks |
|
| pregabalin immediate release capsule | Active Comparator | pregabalin immediate release capsule 75mg bid for 8weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabalin sustained release tablet | Drug | pregabalin sustained release tablet 150mg qd for 8weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 8 in Visual Analogue Scale(VAS) | Baseline/Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 8 in Quality of Life(EQ-5D) | Baseline/Week 8 | |
| Change from baseline to week 8 in Patients Global Impression of Change(PGIC) | Baseline/Week 8 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bon Jeong Ku | Chungnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dankook University Hospital | Cheonan | Chungcheongnam-do | 31116 | South Korea | ||
| Catholic University of Korea's Bucheon St. Mary's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39018898 | Derived | Joung KH, Kim TN, Ku EJ, Lee SS, Yoo WS, Park KS, Kwon SK, Ku BJ. A phase 4 randomized active-controlled clinical study to compare the efficacy and safety of sustained-release pregabalin with immediate-release pregabalin in type 2 diabetic patients with peripheral neuropathic pain. J Diabetes Complications. 2024 Aug;38(8):108809. doi: 10.1016/j.jdiacomp.2024.108809. Epub 2024 Jul 14. |
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| pregabalin immediate release capsule | Drug | pregabalin immediate release capsule 75mg bid for 8weeks |
|
| 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 Morisky Medication Adherence Scale 8-item version(MMAS-8) | Baseline/Week 8 |
| Dose and frequency of Rescue medication(Acetaminophen) | Baseline/Week 8 |
| Number and proportion of subjects with adverse event | Baseline/Week 8 |
| Bucheon-si |
| Gyeonggi-do |
| 14647 |
| South Korea |
| Chungbuk National University Hospital | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Kosin University Gospel Hospital | Busan | 49267 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Daejeon Eulji Medical Center, Eulji University | Daejeon | 35233 | South Korea |
| Chungnam National University Sejong Hospital | Sejong | 30099 | South Korea |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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