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

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Status: Unknown

Conditions: Functional Dyspepsia

Treatments: Drug: A-Cilin®, Clari® and Pantoline®; Drug: Motilitone®

Study type: Interventional

Funder types: Other

Identifiers

NCT02162316

HyFu

Details and patient eligibility

About

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

Full 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

Enrollment: 136 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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136 participants in 2 patient groups

H.Pylori eradication therapy

Active Comparator group

Description:

A-cillin®, Pantoline® and Clari® is administered with a tablet of placebo (Motilitone®)

Treatment:

Drug: A-Cilin®, Clari® and Pantoline®

Motilitone®

Experimental group

Description:

30 mg is administered with 3 tablets of placebo (Patoline®, Clari® and A-cilin)

Treatment:

Drug: Motilitone®