Study to Evaluate the Efficacy between Helicobacter pylori Eradication Therapy and Motilitone in Functional Dyspepsia

A Multi-center, Randomized, Double-blind, Comparative Study to Evaluate the Efficacy between Helicobacter pylori Eradication Therapy and Motilitone in Functional Dyspepsia

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001100

Enrollment

138

Registered

2014-05-09

Start date

2014-05-01

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Expeimental group: H. pylori eradication therapy (pantoprazole 40 mg bid, amoxicillin 1000mg bid, clarithromycin 500 mg bid) and placebo of motilitone 30 mg tid for 1 wk-> placebo of motilitone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) patients of age 20 to 70 2) the patients with functional dyspepsia met the Rome III criteria

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Improvement of symptom (Global assessment of the patients)	—

Secondary

Measure	Time frame
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)	—

Countries

Korea, Republic of

Contacts

Public ContactJi Hye Yu

Chung-Ang Univerisity Hospital

Outcome results