Functional DyspepsiaNCT02162316
A Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia
A study testing Motilitone® and A-Cilin®, Clari® and Pantoline® in people with Functional Dyspepsia, run by Chung-Ang University Hospital at 1 site in South Korea.
Trial summary
This is a clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Motilitone® and A-Cilin®, Clari® and Pantoline®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Oct 2015
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Roman III criteria
- One or more conditions are applied: epigastric pain, epigastric burning, bothersome, postprandial fullness or early satiety
- No organic lesion
- Helicobacter pylori infection
Who cannot join
- has taken prokinetics, H2 antagonists, PPIs, NSAIDs, anticholinergics, antibiotics, antidepressants, anticoagulants within a month
- had a surgery that might affect gastrointestinal motility
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chung-Ang University Hospital
Seoul
Jae Gyu Kim, M.D., Ph.D
About this study
Official title: A Multicenter, Randomized, Double-blind Comparative Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia
This is a clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia
Read the detailed description
This is a multicenter, randomized, double-blind comparative clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia
- Conditions
- Functional Dyspepsia
- Being tested
- Motilitone®, A-Cilin®, Clari® and Pantoline®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motilitone®Drug
A-Cilin®, Clari® and Pantoline®Drug
| Study group | Role | What they receive |
|---|---|---|
| H.Pylori eradication therapy | Active comparator | A-cillin®, Pantoline® and Clari® is administered with a tablet of placebo (Motilitone®) Receives: Drug: A-Cilin®, Clari® and Pantoline® |
| Motilitone® | Experimental | 30 mg is administered with 3 tablets of placebo (Patoline®, Clari® and A-cilin) Receives: Drug: Motilitone® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volunteer global assessment of improvement rate of functional dyspepsia by using 5-Likert scale
5-Likert scale
- deteriorated
- not changed
- moderately improved
- markedly improved
- symptom-free
Measured: 12 weeks
Secondary outcomes (5)
Volunteer global assessment by using 5-Likert scale
Measured: 6 weeks
The improvement rate of 4 types of dyspepsia symptoms
Measured: 12 weeks
The change of each score and total score of dyspeptic symptoms
Measured: 6, 12 weeks
Assessment of NDI-K Quality of Life
Measured: 6,12 weeks
The proportion of the patients who answered "yes for the question about symptom improvement
Measured: 6, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015 (estimated)
- Study completionOct 2015 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Gyu Kim, Chung-Ang University Hospital
- Investigators
- Su Jin Hong, M.D., Ph.D., Principal investigator, Soonchunhyang University HospitalGwang Ha Kim, M.D., Ph.D., Principal investigator, Busan National University HospitalSang Gyun Kim, M.D., Ph.D, Principal investigator, Seoul National University HospitalHyun Soo Kim, M.D., Ph.D, Principal investigator, Chonnam National University HospitalSeong-Woo Jeon, M.D., Ph.D, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162316
- Sponsor's protocol ID
- HyFu
- Status last verified
- Jun 2014
- First submitted
- 11 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind Comparative Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT02162316
- Acronym / sponsor ID
- HyFu
- Conditions
- Functional Dyspepsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 12 Jun 2014 (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 clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia
Detailed description
This is a multicenter, randomized, double-blind comparative clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H.Pylori eradication therapy | Active comparator | Drug: A-Cilin®, Clari® and Pantoline®A-cillin®, Pantoline® and Clari® is administered with a tablet of placebo (Motilitone®) |
| Motilitone® | Experimental | Drug: Motilitone®30 mg is administered with 3 tablets of placebo (Patoline®, Clari® and A-cilin) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Roman III criteria
- One or more conditions are applied: epigastric pain, epigastric burning, bothersome, postprandial fullness or early satiety
- No organic lesion
- Helicobacter pylori infection
Key exclusion criteria (2 listed)
- has taken prokinetics, H2 antagonists, PPIs, NSAIDs, anticholinergics, antibiotics, antidepressants, anticoagulants within a month
- had a surgery that might affect gastrointestinal motility
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 | Motilitone® |
| A-Cilin®, Clari® and Pantoline® | Drug | H.Pylori eradication therapy |
Primary outcome
Volunteer global assessment of improvement rate of functional dyspepsia by using 5-Likert scale
Time frame: 12 weeks
5-Likert scale 1. deteriorated 2. not changed 3. moderately improved 4. markedly improved 5. symptom-free
5 secondary outcomes
Volunteer global assessment by using 5-Likert scale
Time frame: 6 weeks
The improvement rate of 4 types of dyspepsia symptoms
Time frame: 12 weeks
The change of each score and total score of dyspeptic symptoms
Time frame: 6, 12 weeks
Assessment of NDI-K Quality of Life
Time frame: 6,12 weeks
The proportion of the patients who answered "yes for the question about symptom improvement
Time frame: 6, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
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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.
Su Jin Hong, M.D., Ph.D. principal investigator
Soonchunhyang University Hospital
Gwang Ha Kim, M.D., Ph.D. principal investigator
Busan National University Hospital
Sang Gyun Kim, M.D., Ph.D principal investigator
Seoul 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 study testing Motilitone® and A-Cilin®, Clari® and Pantoline® in people with Functional Dyspepsia, run by Chung-Ang University Hospital 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Jun 2014. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Gyu Kim, M.D., Ph.D (82-2-6299-3147, jgkimd@cau.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volunteer global assessment of improvement rate of functional dyspepsia by using 5-Likert scale (time frame: 12 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 24 Jun 2014.