Functional DyspepsiaPhase 4NCT01817465
A Study to Demonstrate the Efficacy and Safety of Motilitone®
A Phase 4 study testing Motilitone ®, Pantoline® and Motilitone® and Pantoline® in people with Functional Dyspepsia, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
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®. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Motilitone ®, Pantoline® and Motilitone® and Pantoline®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Mar 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Roman III criteria
- One or more conditions are applied: epigastralgia, burning feelings in the solar plexus early satiety, uncomfortable fullness
- No organic lesion
Who cannot join
- has been administered or was administered within a month
- had a surgery that might affect gastrointestinal motility
- Tegaserod
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-centers, Randomized, Double-blinded, Parallel Study Study to Evaluate the Efficacy and Safety of Motilitone® in Patients With Functional Dyspepsia.
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®.
- Conditions
- Functional Dyspepsia
- Being tested
- Motilitone ®, Pantoline®, Motilitone® and Pantoline®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motilitone ®Drug
Pantoline®Drug
Motilitone® and Pantoline®Drug
| Study group | Role | What they receive |
|---|---|---|
| Motilione® | Experimental | 30 mg is administered with a tablet of placebo (Pantoline®) Receives: Drug: Motilitone ® |
| Pantoline® | Active comparator | 40mg is administered with a tablet of Motilitone® Receives: Drug: Pantoline® |
| Motilitone® and Pantoline® | Active comparator | Both drugs are administered at once Receives: Drug: Motilitone® and Pantoline® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (3)
Number of dyspepsia(indigestion) symptoms occurred (Counted daily)
Measured: 6 weeks
Assessment of NDI-K Quality of Life
Measured: 6 weeks
Soreness of digestive symptoms (dyspepsia) evaluated its intensity on a scale of 1 to 5
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startAug 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung Kyu Choi, M.D., Ph.D., Principal investigator, The Catholic University of KoreaKyu Chan Huh, M.D., Ph.D., Principal investigator, Konyang University HospitalSung Kook Kim, M.D., Ph.D., Principal investigator, Kyungpook National University HospitalKyung Sik Park, M.D., Ph.D., Principal investigator, Keimyung University Dongsan Medical CenterJoong Gu Gweon, M.D.,Ph.D., Principal investigator, Daegu Catholic University Medical CenterGeun Am Song, M.D., Ph.D., Principal investigator, Busan National University HospitalSoo Jin Hong, M.D., Ph.D., Principal investigator, Soonchunhyang University HospitalNa Young Kim, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817465
- Sponsor's protocol ID
- DA9701_PPI_IV
- Status last verified
- Jan 2015
- First submitted
- 19 Mar 2013
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centers, Randomized, Double-blinded, Parallel Study Study to Evaluate the Efficacy and Safety of Motilitone® in Patients With Functional Dyspepsia.
- ClinicalTrials.gov ID
- NCT01817465
- Acronym / sponsor ID
- DA9701_PPI_IV
- Conditions
- Functional Dyspepsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 25 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motilione® | Experimental | Drug: Motilitone ®30 mg is administered with a tablet of placebo (Pantoline®) |
| Pantoline® | Active comparator | Drug: Pantoline®40mg is administered with a tablet of Motilitone® |
| Motilitone® and Pantoline® | Active comparator | Drug: Motilitone® and Pantoline®Both drugs are administered at once |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Roman III criteria
- One or more conditions are applied: epigastralgia, burning feelings in the solar plexus early satiety, uncomfortable fullness
- No organic lesion
Key exclusion criteria (3 listed)
- has been administered or was administered within a month
- had a surgery that might affect gastrointestinal motility
- Tegaserod
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motilitone ® | Drug | Motilione® |
| Pantoline® | Drug | Pantoline® |
| Motilitone® and Pantoline® | Drug | Motilitone® and Pantoline® |
Primary outcome
Subject global assessment by using 5-Likert scale and Binary outcome methods
Time frame: 6 weeks
5-Likert scale: 0: worse 1. similar 2. improved in some degree 3. considerably improved 4. completely cured Binary outcome: yes/no
3 secondary outcomes
Number of dyspepsia(indigestion) symptoms occurred (Counted daily)
Time frame: 6 weeks
Assessment of NDI-K Quality of Life
Time frame: 6 weeks
Soreness of digestive symptoms (dyspepsia) evaluated its intensity on a scale of 1 to 5
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myung Kyu Choi, M.D., Ph.D. principal investigator
The Catholic University of Korea
Kyu Chan Huh, M.D., Ph.D. principal investigator
Konyang University Hospital
Sung Kook Kim, M.D., Ph.D. principal investigator
Kyungpook National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Motilitone ®, Pantoline® and Motilitone® and Pantoline® in people with Functional Dyspepsia, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject global assessment by using 5-Likert scale and Binary outcome methods (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2015.