Functional Dyspepsia
Conditions
Brief 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®.
Interventions
DRUGMotilitone ®
DRUGPantoline®
DRUGMotilitone® and Pantoline®
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject global assessment by using 5-Likert scale and Binary outcome methods | 6 weeks | 5-Likert scale: 0: worse 1. similar 2. improved in some degree 3. considerably improved 4. completely cured Binary outcome: yes/no |
Secondary
| Measure | Time frame |
|---|---|
| Soreness of digestive symptoms (dyspepsia) evaluated its intensity on a scale of 1 to 5 | 6 weeks |
| Number of dyspepsia(indigestion) symptoms occurred (Counted daily) | 6 weeks |
| Assessment of NDI-K Quality of Life | 6 weeks |
Countries
South Korea
Outcome results
None listed