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This is a phase IV clinical study to evaluate the preventive effectiveness of NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind, active-controlled, stratified randomized, parallel group. A tablet of DA9601, Cytotec (200ug of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects for four weeks.
After filling an Informed consent form, subjects are joined the clinical trials. First of all, Screening test including the endoscopy test is performed.
Subjects, which fit the inclusion/Exclusion criteria, are assigned randomly. Subjects takes investigation products as randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stillen | Experimental | Patients taking a tab of Stillen and a tab of placebo drug and a tab of NSAID |
|
| Cytotec | Active Comparator | The subjects taking a tab of Cytotec, a tab of placebo drug, and a tab of NSAID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stillen | Drug |
| ||
| Cytotec (reference drug) |
| Measure | Description | Time Frame |
|---|---|---|
| the percentage of protected subjects (%) | the definition of "protected" is the subjects with no erosions, in other words, either zero or 1 erosion found at stomach by the endoscopy. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| A percentage of a protected subject (at duodenum), and of ulcer occurrence |
| 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang-Yong Seol, MD | Inje University | Study Chair |
| Myoung-Gyu Choi, MD | The Catholic University of Korea | Principal Investigator |
| Oh Young Lee, MD | Hanyang University | Principal Investigator |
| Dong Ho Lee, MD | Seoul National University Bundang Hospital | Principal Investigator |
| Yong Chan Lee, MD | Severance Hospital | Principal Investigator |
| Suck Chei Choi, MD | Wonkwang University School of Medicine & Hospital | Principal Investigator |
| Jong Sun Rew, MD | Chonnam National University Hospital | Principal Investigator |
| Kang Moon Lee | Saint Vincent's Hospital, Korea | Principal Investigator |
| Jae Young Jang, MD | Kyunghee University Medical Center | Principal Investigator |
| Hoon-jai Chun, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | 614735 | South Korea |
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| ID | Term |
|---|---|
| C116959 | DA 9601 |
| D016595 | Misoprostol |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| C056498 | aceclofenac |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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|
| NSAID (Aceclofenac) | Drug |
|
| Korea University Anam Hospital |
| Principal Investigator |
| Sang-woo Lee, MD | Korea University Ansan Hospital | Principal Investigator |
| Moo In Park, MD | Kosin University Gospel Hospital | Principal Investigator |
| Joong Goo Kwon, MD | Daegu Catholic University Medical Center | Principal Investigator |
| Geunam Song, MD | Pusan National University Hospital | Principal Investigator |
| Seong Woo Jeon, MD | Kyungpook National University Medical Center | Principal Investigator |
| Soo Taek Lee, MD | Chonbuk National University Hospital | Principal Investigator |
| Jae Gyu Kim, MD | Chung-Ang University Hospital | Principal Investigator |
| Poong-Lyul Rhee, MD | Samsung Medical Center | Principal Investigator |
| Kwang Jae Lee, MD | Ajou University School of Medicine | Principal Investigator |
| Hyo Jin Park, MD | Gangnam Severance Hospital | Principal Investigator |
| Byung Ik Jang, MD | Yeungnam University Hospital | Principal Investigator |
| Yong Woon Shin, MD | Inha University Hospital | Principal Investigator |
| Dong Soo Han, MD | Hanyang University Guri Hospital | Principal Investigator |
| Sung Kook Kim, MD | Kyungpook National University Hospital | Principal Investigator |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |