None listed
Conditions
Interventions
Drug : Subjects will be assigned to one of below groups through Randomizatoin.
1) Administration of Celecoxib 200mg twice a day
2) Co-administration of Aceclofenac 100mg twice and Ilaprazole 10mg once
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Man or Woman with the age of between 19 and 80 2) Those who need to take non selective Non-Steroidal Anti-Inflammatory Drug (NSAID) due to Arthritis Rheumatoid, Osteoarthritis and any other diseases 3) Those who were tested negative for H.pylori through medical history
Exclusion criteria
Exclusion criteria: 1) Those with Esophageal stenosis, UIceric stenosis, Esophageal/Gastric Variceal bleeding, Barrett esophagus, Active peptic ulcer, Gastrointestinal bleeding, Malignant tumor confirmed by previous upper gastrointestinal endoscopy 2) Those who have experienced sensitive reaction to Ilaprazole, Aceclofenac and Celecoxib 3) Those who have taken H2 receptor blocker, Prostaglandin products, Mucosal protector, Prokinetis and etc that have impact on Gastric acid release within 4 weeks before administration of Investigational Products. 4) Those who should continue to take other NSAID including Aspirin(Above 325mg a day) except Investigational Products, Steroid Products, Anticoagulants during this clinical Trial. 5) Those with history of asthma, acute rhinitis, nasal polyp, angioedema, urticaria, allergic reaction, gastrointestinal bleeding or perforation related to aspirin or other NSAID including COX-2 inhibitor. 6) Those with Congestive heart failure (NYHA class II! IV) or confirmed ischaemic heart diseases, peripheral arterial disease or Cerebrovascular diseases 7) Those who received treatment for pain caused before or after coronary artery bypass graft (CABG) 8) Hyperkalemia patient 9) Those with bleeding or coagulation disorder 10) Those with Chronic liver or renal failure 11) Those with the history of Gastric acid suppression surgery or Gaastric, duodenal surgery 12) Those with zollinger-Ellison syndrome or alcohol addict or those with drug abuse history 13) Those with inflammatory bowel disease such as Crohn's disease, Ulcerative colitis 14) Those with the history of Malignant tumor (except Basal cellcarcinoma of the skin)within 5 years before Screening 15) Those who are not aware of whether H.pylori is positive 16) Those who are currently taking Atazanavir or Rilpivirin 17) Pregnant (or possible pregnancy) and lactating women 18) A woman who does not use medically acceptable contraception during the clinical trial (Menopausal women who are at least 12 months of amenorrhea are considered to be non-working women) 19) Those with genetic disorder such as Galactose intolerance, Lapp lactose deficiency, or Glucose-galactose malabsorption and so on 20) Those who attended other clinical trial within 6 months before Screening 21) Patients whom other researchers deemed inappropriate for participation in clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Leeds dyspepsia questionnaire (LDQ) Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Short Form-36 (SF-26) Score | — |
Countries
Korea, Republic of
Contacts
Public ContactHojoong Kim
Seoul National University Bundang Hospital
Outcome results
None listed