A Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind Comparative Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02162316
• Other study ID #: HyFu
• Status: Not yet recruiting
• Phase: N/A
• First received: June 11, 2014
• Last updated: June 23, 2014
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: June 2014
• Source: Chung-Ang University Hospital
• Contact: Jae Gyu Kim, M.D., Ph.D
• Phone: 82-2-6299-3147
• Email: jgkimd[@]cau.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

This is a clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia

Description:

This is a multicenter, randomized, double-blind comparative clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 136
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Roman III criteria

• One or more conditions are applied: epigastric pain, epigastric burning, bothersome, postprandial fullness or early satiety

• No organic lesion

• Helicobacter pylori infection

Exclusion Criteria:

• has taken prokinetics, H2 antagonists, PPIs, NSAIDs, anticholinergics, antibiotics, antidepressants, anticoagulants within a month

• had a surgery that might affect gastrointestinal motility

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis

Intervention

Drug:
• Motilitone®

• A-Cilin®, Clari® and Pantoline®

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chung-Ang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volunteer global assessment of improvement rate of functional dyspepsia by using 5-Likert scale	5-Likert scale; deteriorated; not changed; moderately improved; markedly improved; symptom-free	12 weeks	No
Secondary	Volunteer global assessment by using 5-Likert scale		6 weeks	No
Secondary	The improvement rate of 4 types of dyspepsia symptoms		12 weeks	No
Secondary	The change of each score and total score of dyspeptic symptoms		6, 12 weeks	No
Secondary	Assessment of NDI-K Quality of Life		6,12 weeks	No
Secondary	The proportion of the patients who answered "yes for the question about symptom improvement		6, 12 weeks	No