8 completed, 5 unknown, 1 terminated. 7 Phase 3, 6 Phase 4, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 5, Terminated 1, Unknown 1 |
| Phase 4 | 6 | Completed 3, Unknown 3 |
| Phase 2 | 1 | Unknown 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Effect of Bioflor on Gut Microbiota in Proton-Pump Inhibitor Users Saccharomyces Boulardii 250 MG, Proton Pump Inhibitors (PPI) - Dysbiosis, Gastroesophageal Reflux Disease (GERD) | Phase 4 | Completed | Seoul National University Hospital | 80 | 2024-07-18 | 2026-10-01 |
| The Comparison of Effect Between Salsalate and Placebo in Osteoarthritis With Nonalcoholic Fatty Liver Disease Salsalate, Placebo - Non Alcoholic Fatty Liver, Osteo Arthritis | Phase 4 | Completed | Korea University Guro Hospital | 34 | 2017-11-08 | 2019-08-22 |
| Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson Disease Melatonin PR, Clonazepam, Melatonin PR placebo - REM Sleep Behavior Disorder, Parkinson Disease | Phase 2 | Unknown | Seoul National University Hospital | 30 | 2016-07-01 | 2016-06-03 |
| Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Calcium Monotherapy While LDL-C is Properly Controlled KI1106 4g, QD, Atorvastatin Calcium 20mg, QD - Dyslipidemias | Phase 3 | Completed | Kuhnil Pharmaceutical Co., Ltd. | 215 | 2016-05-04 | 2018-11-19 |
| Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease Melatonin(Circadin®), Placebo Oral Tablet - Parkinson's Disease | Phase 4 | Unknown | KIMJisun | 82 | 2016-01-13 | 2017-08-23 |
| Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease Melatonin(Circadin®), Placebo - Parkinson's Disease | Phase 4 | Unknown | Kuhnil Pharmaceutical Co., Ltd. | 100 | 2016-01-01 | 2016-05-18 |
| Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled KI1107 4 Capsules, QD, Rosuvastatin Calcium 20 MG, QD - Dyslipidemias | Phase 3 | Completed | Kuhnil Pharmaceutical Co., Ltd. | 215 | 2014-05-01 | 2017-01-20 |
| Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3-acids Ethylesters 90 in Type Ⅱb Hyperlipidemia Atorvastatin 20mg, Omega-3-acids ethylesters 90 4g, Placebo(Omega-3-acids ethylesters 90) - Hyperlipidemia, Familial Combined | Phase 3 | Unknown | Kuhnil Pharmaceutical Co., Ltd. | 80 | 2014-01-01 | 2014-03-20 |
| Efficacy and Safety of KI1001 in the Treatment of ≥ 55 Years Old Insomnia Patients KI1001, Placebo - Sleep Initiation and Maintenance Disorders | Phase 3 | Completed | Kuhnil Pharmaceutical Co., Ltd. | 80 | 2013-08-01 | 2014-03-14 |
| Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junction Cancer Irinotecan, Nimotuzumab - Gastric Cancer, Gastroesophageal Junction Cancer | Phase 3 | Terminated | Kuhnil Pharmaceutical Co., Ltd. | 400 | 2013-05-13 | 2018-03-26 |
| Efficacy and Safety of KI1001 in ≥ 55 Years Old Insomnia Patients KI1001, Placebo KI1001 - Sleep Initiation and Maintenance Disorders | Phase 3 | Completed | Kuhnil Pharmaceutical Co., Ltd. | 170 | 2011-03-01 | 2012-04-24 |
| The Effects of Omega-3 Fatty Acid (OMACOR) on the Low-density Lipoprotein (LDL) Sub-fraction in Type 2 Diabetic Patients Omega-3 acid 4 grams per day, Placebo control - Diabetes Mellitus, Type 2, Hypercholesterolemia | Phase 4 | Unknown | Inje University | 70 | 2009-07-01 | 2009-08-06 |
| Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia Omega-3-acids ethylesters 90 4g, Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin - Diabetes Mellitus, Type 2, Hypertriglycemia | Phase 4 | Completed | Kuhnil Pharmaceutical Co., Ltd. | 68 | 2009-02-01 | 2014-12-02 |
| Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A Nephropathy Omega-3 fatty acid ethylester90 - IgA Nephropathy | Phase 3 | Completed | Kuhnil Pharmaceutical Co., Ltd. | 152 | 2007-11-01 | 2012-09-27 |
Parkinson Disease (3) · Diabetes Mellitus, Type 2 (2) · Dyslipidemias (2) · Parasomnias (2) · Sleep Initiation and Maintenance Disorders (2) · Diabetes Mellitus (1) · Dysbiosis (1) · Gastroesophageal Reflux (1) · Glomerulonephritis, IGA (1) · Hypercholesterolemia (1) · Hyperlipidemia, Familial Combined (1) · Hypertriglyceridemia (1) · Non-alcoholic Fatty Liver Disease (1) · REM Sleep Behavior Disorder (1) · Stomach Neoplasms (1)
Atorvastatin (3) · Omacor (2) · Rosuvastatin Calcium (2) · Clonazepam (1) · Irinotecan (1) · Melatonin (1) · Pravastatin (1) · Proton Pump Inhibitors (1) · Simvastatin (1) · nimotuzumab (1) · salicylsalicylic acid (1)
South Korea (10) · Japan (1) · Taiwan (1)
Doo-Heum Park, M.D., Ph.D. (2) · Eungseok Oh (2) · Jinse Park (2) · Jisun Kim (2) · Seung-Chul Hong, M.D., Ph.D. (2) · Won-Chul Shin, M.D., Ph.D. (2) · Wooyoung Jang (2) · Beomseok Jeon, MD, PhD (1) · Byung-Joo Park, MD,PhD,FISPE (1) · Hee Kyoung Cheon, Ph.D. (1) · Hong Seog Seo, Ph.D. (1) · In-Young Yoon, M.D., Ph.D. (1) · Jee-Hyun Kim, M.D., Ph.D. (1) · Jeong H Park, M.D., Ph.D. (1) · Ji Hoon Kim, MD (1)