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Completed

NCT Number: NCT01817465

A Study to Demonstrate the Efficacy and Safety of Motilitone®

This is a phase IV , comparative study to evaluate the efficacy and safety of Motiltone® in treatment of the patients with functional dyspepsia. The study is conducted with following methods: multi-centers, double blind, randomization, parallel. The subjects will receive Motilitone® or/and Pantoline®.

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Key information

Conditions

Functional Dyspepsia

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ajou University Medical Center

Suwon, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Roman III criteria
  • One or more conditions are applied: epigastralgia, burning feelings in the solar plexus early satiety, uncomfortable fullness
  • No organic lesion

Exclusion criteria

  • has been administered or was administered within a month
  • had a surgery that might affect gastrointestinal motility
  • Tegaserod

Treatment and study plan

Motilitone ®

Drug

Pantoline®

Drug

Motilitone® and Pantoline®

Drug

Primary outcomes

  1. Subject global assessment by using 5-Likert scale and Binary outcome methods

    Time frame: 6 weeks

    5-Likert scale: 0: worse

    • similar
    • improved in some degree
    • considerably improved
    • completely cured

    Binary outcome:

    yes/no

Secondary outcomes

  1. Number of dyspepsia(indigestion) symptoms occurred (Counted daily)

    Time frame: 6 weeks

  2. Assessment of NDI-K Quality of Life

    Time frame: 6 weeks

  3. Soreness of digestive symptoms (dyspepsia) evaluated its intensity on a scale of 1 to 5

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

A Multi-centers, Randomized, Double-blinded, Parallel Study Study to Evaluate the Efficacy and Safety of Motilitone® in Patients With Functional Dyspepsia.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 25, 2013
Registry last updated
Jan 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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