A Study to Demonstrate the Efficacy and Safety of Motilitone®

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817465
• Other study ID #: DA9701_PPI_IV
• Status: Completed
• Phase: Phase 4
• First received: March 19, 2013
• Last updated: January 25, 2015
• Start date: August 2012
• Est. completion date: March 2014

Study information

• Verified date: January 2015
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

Drug:
• Motilitone ®

• Pantoline®

• Motilitone® and Pantoline®

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Medical Center	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject global assessment by using 5-Likert scale and Binary outcome methods	5-Likert scale: 0: worse; similar; improved in some degree; considerably improved; completely cured; Binary outcome: yes/no	6 weeks	No
Secondary	Number of dyspepsia(indigestion) symptoms occurred (Counted daily)		6 weeks	No
Secondary	Assessment of NDI-K Quality of Life		6 weeks	No
Secondary	Soreness of digestive symptoms (dyspepsia) evaluated its intensity on a scale of 1 to 5		6 weeks	No