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| Name | Class |
|---|---|
| Dong-A ST Co., Ltd. | INDUSTRY |
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The purpose of this study is to evaluate the efficacy of eupatilin on the prevention of gastroenteropathy in patients with NSAIDs and low dose steroid by comparing with rebamipide.
After being informed of the study and potential risks, all patients giving written informed consents will undergo a 1-week screening period to determine eligibility for study entry. During screening period, patients will undergo fecal calprotectin test, upper endoscopy and submit symptom diary. At week 0, subjects who meet the eligibility criteria will be randomized in a open labeled manner in 1:1 ratio to eupatilin (90mg twice daily-test group, 25 patients) or rebamipide (100mg three times daily-control group paients) for 8 weeks. At week 8, subjects undergo fecal calprotectin test, upper endoscopy and submit symptom diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eupatilin | Experimental | take eupatilin to prevent NSAID induced gastroenteropathy |
|
| rebamipide | Active Comparator | take rebamipide to prevent NSAID induced gastroenteropathy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eupatilin | Drug | take eupatilin to prevent NSAID induced gastroenteropathy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with gastric damage | Percentage of patients with endoscopic Modified Lanza Score >3 | evaluated at day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of gastric erosion number | Change of gastric erosion number at day 56 compared with that at day 0 | evaluated at day 0 and day 56 |
| Change of Modified Lanza Score | Change of Modified Lanza Score at day 56 compared with that at day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12035587 | Background | Sperling RL. NSAIDs. Home Healthc Nurse. 2001 Nov;19(11):687-9. doi: 10.1097/00004045-200111000-00011. No abstract available. | |
| 22193214 | Background | Conaghan PG. A turbulent decade for NSAIDs: update on current concepts of classification, epidemiology, comparative efficacy, and toxicity. Rheumatol Int. 2012 Jun;32(6):1491-502. doi: 10.1007/s00296-011-2263-6. Epub 2011 Dec 23. |
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| Rebamipide |
| Drug |
take rebamipide to prevent NSAID induced gastroenteropathy |
|
| evaluated at 0 day and day 56 |
| Change of duodenal erosion number | Change of duodenal erosion number at day 56 compared with that at day 0 | evaluated at day 0 and day 56 |
| Gastrointestinal symptom | Gastrointestinal symptom change using survey at day 56 compared with that at day 0 | evaluated at day 0 and day 56 |
| Fecal calprotectin | Fecal calprotectin level change at visit 3 compared with visit 0 | evaluated at day 0 and day 56 |
| Antioxidant gene expression | Antioxidant gene expression change at day 56 compared with that at day 0 | evaluated at day 0 and day 56 |
| 11276797 | Background | MacDonald TM. Epidemiology and pharmacoeconomic implications of non-steroidal anti-inflammatory drug-associated gastrointestinal toxicity. Rheumatology (Oxford). 2000 Dec;39 Suppl 2:13-20; discussion 57-9. doi: 10.1093/rheumatology/39.suppl_2.13. |
| 21468265 | Background | Lee SH, Han CD, Yang IH, Ha CW. Prescription pattern of NSAIDs and the prevalence of NSAID-induced gastrointestinal risk factors of orthopaedic patients in clinical practice in Korea. J Korean Med Sci. 2011 Apr;26(4):561-7. doi: 10.3346/jkms.2011.26.4.561. Epub 2011 Mar 28. |
| 29847892 | Background | Shim KN, Kim JI, Kim N, Kim SG, Jo YJ, Hong SJ, Shin JE, Kim GH, Park KS, Choi SC, Kwon JG, Kim JH, Kim HJ, Kim JW. The efficacy and safety of irsogladine maleate in nonsteroidal anti-inflammatory drug or aspirin-induced peptic ulcer and gastritis. Korean J Intern Med. 2019 Sep;34(5):1008-1021. doi: 10.3904/kjim.2017.370. Epub 2018 Jun 1. |
| Background | Julious S. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut Statist. 2005;4:287-291. |
| 17410467 | Background | Kim HK, Kim JI, Kim JK, Han JY, Park SH, Choi KY, Chung IS. Preventive effects of rebamipide on NSAID-induced gastric mucosal injury and reduction of gastric mucosal blood flow in healthy volunteers. Dig Dis Sci. 2007 Aug;52(8):1776-82. doi: 10.1007/s10620-006-9367-y. Epub 2007 Apr 5. |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| D013167 | Spondylitis, Ankylosing |
| D013276 | Stomach Ulcer |
| D004751 | Enteritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
| D005759 | Gastroenteritis |
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| ID | Term |
|---|---|
| C045325 | eupatilin |
| C052785 | rebamipide |
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