A Study to Demonstrate the Efficacy and Safety of Motilitone®
Phase 4
Completed
- Conditions
- Functional Dyspepsia
- Interventions
- Drug: Motilitone® and Pantoline®Drug: Motilitone ®Drug: Pantoline®
- Registration Number
- NCT01817465
- Lead Sponsor
- Dong-A ST Co., Ltd.
- 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®.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 389
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Motilitone® and Pantoline® Motilitone® and Pantoline® Both drugs are administered at once Motilione® Motilitone ® 30 mg is administered with a tablet of placebo (Pantoline®) Pantoline® Pantoline® 40mg is administered with a tablet of Motilitone®
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number of dyspepsia(indigestion) symptoms occurred (Counted daily) 6 weeks Soreness of digestive symptoms (dyspepsia) evaluated its intensity on a scale of 1 to 5 6 weeks Assessment of NDI-K Quality of Life 6 weeks
Trial Locations
- Locations (1)
Ajou University Medical Center
🇰🇷Suwon, Korea, Republic of