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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-10-31

Brief Summary

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

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Detailed Description

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

Conditions

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Functional Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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H.Pylori eradication therapy

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

Group Type ACTIVE_COMPARATOR

A-Cilin®, Clari® and Pantoline®

Intervention Type DRUG

Motilitone®

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

Group Type EXPERIMENTAL

Motilitone®

Intervention Type DRUG

Interventions

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Motilitone®

Intervention Type DRUG

A-Cilin®, Clari® and Pantoline®

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No