None listed
Conditions
Interventions
Drug, Procedure/Surgery : 1. drug - concomitants (NSIADs) during 4wks, 100mg BID
investigational (150mg or 300mg) or placebo during 4wks, BID
2. gastroscopy/capsule endoscopy, two times (ba
Sponsors
Kuhnil Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patient who is 18 ~ 80 years old by Korean age 2. Patient who has given freely written informed consent to participate in this trial 3. Osteoarthritis or rheumatic arthritis patient who needs medication of NSAIDs at least 1 month or more 4. Less than 5 small bowels' erosion in capsule endoscopy at screening period 5. Patient who was found no significant enteropathy in capsule endoscopy at screening period 6. Patient who was found no significant gastropathy in gastroscopy at screening period
Exclusion criteria
Exclusion criteria: 1)Patient who has ulcer (except of scar) in gastro or/and small intestine 2)Patient who has hemorrhage (include hemorrhagic gastritis) or history of NSAIDs associated hemorrhage before 3)Patient who has reflux esophagitis of B, C, D group by LA classification 4)Patient who was made the diagnosis or R/O of enterostenosis totaly 5)Patient who has been gastrectomy before 6)Patient who is having Cancer in digestive system 7)Patient who has cardiovascular disease 8)Pathent who has been or expects to CABG less than 6 months from Visit 1 9)Patient who has been taken anti-uncer agent , H2 receptor antagonist, muscarinic receptor antagonist, aspirin, defensive factor elevating agent, TNF antagonist, Metronidazole, Sulfasalazine or drug maybe influence on NSAIDs or gastrointestinal motility 10)Pregnant (if she is on childbearing period, the result of HCG urine test should be positive) or breast-feeding woman 11)Childbearing woman who does not agree with appropriate contraception during trial period (appropriate contraception: contraceptive, sterile operation-vasectomy and tubal ligation, contraceptive device, condom, spermicide etc.) 12)Patient who had the value of Hb<10g/dl(female), <11g/dl(male) at screening blood hematology 13)Renal failure patient who had double value of Cr than upper normal range at screening blood chemistry 14)Hepatic failure patient who had double value of AST/ALT than upper normal range at screening blood chemistry 15)Asthma patient who could have possibility of increasing asthma symptom or occurring cnidosis or acute rhinitis caused by aspirin or another prostaglandin synthetase inhibitor 16)Patient who has been had hypersensitiveness related to Zinc or NSAID same as agent of this trial’s IP before 17)Patient who has been had alcohol abuse or drug misuse 18)Patient who received another IP within 4 weeks before registration 19)Other patients who are considered to be unsuitable for this trial by investigators or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| preventive rate of small bowel's erosion;change rate of small intestine lesion and hemoglobin, hematocrit | — |
Secondary
| Measure | Time frame |
|---|---|
| safety(AE, Laboratory test, physical examination, Vital Sign, E.K.G) | — |
Countries
Korea, Republic of
Contacts
Public ContactJu-mi Hong
Kuhnil Pharm
Outcome results
None listed