A Study to Demonstrate the Efficacy and Safety of Motilitone®

Dong-A ST

Status and phase: Completed; Phase 4

Conditions: Functional Dyspepsia

Treatments: Drug: Pantoline®; Drug: Motilitone® and Pantoline®; Drug: Motilitone ®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01817465

DA9701_PPI_IV

Details and patient eligibility

About

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®.

Enrollment: 389 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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389 participants in 3 patient groups

Motilione®

Experimental group

Description:

30 mg is administered with a tablet of placebo (Pantoline®)

Treatment:

Drug: Motilitone ®

Pantoline®

Active Comparator group

Description:

40mg is administered with a tablet of Motilitone®

Treatment:

Drug: Pantoline®

Motilitone® and Pantoline®

Active Comparator group

Description:

Both drugs are administered at once

Treatment:

Drug: Motilitone® and Pantoline®