KCT0004786已完成未知
A comparative study of celecoxib monotherapy versus aceclofenac and ilaprazole combination therapy for the treatment of dyspepsia caused by NSAID
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 139
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
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