Study to Evaluate the Efficacy between Helicobacter pylori Eradication Therapy and Motilitone in Functional Dyspepsia
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0001100
- Lead Sponsor
- Chung-Ang Univerisity Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 138
1) patients of age 20 to 70
2) the patients with functional dyspepsia met the Rome III criteria
1) Pregnant or lactating women, child bearing women not using a proper contraception
2) Patients with previous gastrointestinal surgery
3) Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
4) who had bowel symptoms suggestive of irritable bowel syndrome (Rome III criteria)
5)who had reflux esophagitis, peptic ulcers (active or healing stage), gastric adenocarcinoma, esophageal carcinoma, pancreatic disease(pancreatitis, pancreatic cancer, etc), biliary disease, inflammatory bowel disease during recent 6 months
6) previous eradication therapy for H. pylori
7) uncontrolled diabetes mellitus and hypertension
8) hepatic abnormality (more than 3 folds of upper normal limit in AST(Aspartate Aminotransferase)/ALT(Alanine Aminotransferase)
9) renal dysfunction (more than 2 folds of upper normal limit in serum creatinine
10) severe disease for heart, lung, hematology, and endocrine system
11) alcoholism, psycosis, neurosis, drug addiction status
12)who were treated by histamine-receptor antagonists,proton pump inhibitors, prostaglandins, prokinetics, bismuthcontaining compounds, or antibiotics during 2 weeks before the study began
13) Allergic disease for experimental medicine
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of symptom (Global assessment of the patients)
- Secondary Outcome Measures
Name Time Method Improvement of symptom (Global assessment of the patients);the effective ratio of four symptoms for functional dyspepsia;total symptom score and individual symptom score;The change of the quality of life using NDI-K(Nepean dyspepsia index-Korean)