Comparative evaluation of Digest disorder caused by administration of painkiller after administration of Celecoxib alone or concomitant that of Aceclofenac and Ilaprazole
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0004786
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Dyspepsia is a common adverse event associated with the use of nonsteroidal anti- inflammatory drugs (NSAIDs) in patients with lumbar spinal stenosis. Although proton pump and cyclooxygenase-2 inhibitors are potential treatment options, the optimal strategy remains unclear. This study aimed to compare the efficacy and safety of combination therapy with aceclofenac and ilaprazole versus celecoxib monotherapy for the treatment of dyspepsia caused by NSAID use in patients with lumbar spinal stenosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 139
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Leeds dyspepsia questionnaire (LDQ) Score
- Secondary Outcome Measures
Name Time Method Change in Short Form-36 (SF-26) Score