Functional DyspepsiaPhase 3NCT03225248
Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia
A Phase 3 study testing UI05MSP015CT and Gasmotin in people with Functional Dyspepsia, run by Korea United Pharm. Inc..
Trial summary
This study is a multi-center, randomized, active-controlled, double-blind, non-inferiority, phase III clinical trial evaluating efficacy and safety of once-daily mosapride (UI05MSP015CT) in patients with functional dyspepsia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- UI05MSP015CT and Gasmotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- 5 Nov 2014to 12 Oct 2015
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >19 years
- Diagnosis of functional dyspepsia meeting Rome III criteria
- At least three moderate or severe symptoms included in the Symptom Score
- No structural lesions of upper gastrointestinal tract
Who cannot join
- History of dyspepsia unrelated to functional dyspepsia or diseases
- History of gastrointestinal surgery
- History of malignancy in the previous 5 years
- Psychiatric disorders including major depressive disorder and anxiety
- Liver cirrhosis or abnormal liver laboratory findings
- Advanced chronic kidney disease
Show all 10Show fewer
- Uncontrolled hypertension
- Uncontrolled diabetes
- Pregnancy and lactation
- Recent history of taking medication affecting the gastrointestinal system
About this study
Official title: Multi-center, Randomized, Active-Controlled, Double-Blind, Non-Inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia (MARS Study)
This study is a multi-center, randomized, active-controlled, double-blind, non-inferiority, phase III clinical trial evaluating efficacy and safety of once-daily mosapride (UI05MSP015CT) in patients with functional dyspepsia.
Read the detailed description
Patients with functional dyspepsia were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once daily before breakfast, study group) or mosapride (5 mg three times a day before each meal, control group) and corresponding placebo t.i.d. or q.d. for 4 weeks.
- Conditions
- Functional Dyspepsia
- Being tested
- UI05MSP015CT, Gasmotin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UI05MSP015CTDrug
UI05MSP015CT and Placebo of Gasmotin
GasmotinDrug
Placebo of UI05MSP015CT and Gasmotin
| Study group | Role | What they receive |
|---|---|---|
| UI05MSP015CT | Experimental | UI05MSP015CT and Placebo of Gasmotin Receives: Drug: UI05MSP015CT |
| Gasmotin | Active comparator | Placebo of UI05MSP015CT and Gasmotin Receives: Drug: Gasmotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of symptom score of functional dyspepsia
Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.
Measured: 4weeks
Secondary outcomes (3)
Change of symptom score of functional dyspepsia
Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.
Measured: 2weeks
General symptom improvement
Selecting: 'loss of symptom', 'apparent improvement', 'moderate improvement', 'no change', and 'deterioration'.
Measured: 2weeks, 4weeks
NDI-K questionnaire
25 questions on five quality of life areas
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start5 Nov 2014
- Primary completion5 Sep 2015
- Study completion12 Oct 2015
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea United Pharm. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225248
- Sponsor's protocol ID
- KUP-MSP5-301
- Status last verified
- Jul 2017
- First submitted
- 12 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Active-Controlled, Double-Blind, Non-Inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia (MARS Study)
- ClinicalTrials.gov ID
- NCT03225248
- Acronym / sponsor ID
- KUP-MSP5-301
- Conditions
- Functional Dyspepsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Korea United Pharm. Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2014 (actual)
- Primary completion
- 5 Sep 2015 (actual)
- Study completion
- 12 Oct 2015 (actual)
- First posted
- 21 Jul 2017 (actual)
- 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 study is a multi-center, randomized, active-controlled, double-blind, non-inferiority, phase III clinical trial evaluating efficacy and safety of once-daily mosapride (UI05MSP015CT) in patients with functional dyspepsia.
Detailed description
Patients with functional dyspepsia were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once daily before breakfast, study group) or mosapride (5 mg three times a day before each meal, control group) and corresponding placebo t.i.d. or q.d. for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UI05MSP015CT | Experimental | Drug: UI05MSP015CTUI05MSP015CT and Placebo of Gasmotin |
| Gasmotin | Active comparator | Drug: GasmotinPlacebo of UI05MSP015CT and Gasmotin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >19 years
- Diagnosis of functional dyspepsia meeting Rome III criteria
- At least three moderate or severe symptoms included in the Symptom Score
- No structural lesions of upper gastrointestinal tract
Key exclusion criteria (10 listed)
- History of dyspepsia unrelated to functional dyspepsia or diseases
- History of gastrointestinal surgery
- History of malignancy in the previous 5 years
- Psychiatric disorders including major depressive disorder and anxiety
- Liver cirrhosis or abnormal liver laboratory findings
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 |
|---|---|---|
| UI05MSP015CTUI05MSP015CT and Placebo of Gasmotin | Drug | UI05MSP015CT |
| GasmotinPlacebo of UI05MSP015CT and Gasmotin | Drug | Gasmotin |
Primary outcome
Change of symptom score of functional dyspepsia
Time frame: 4weeks
Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.
3 secondary outcomes
Change of symptom score of functional dyspepsia
Time frame: 2weeks
General symptom improvement
Time frame: 2weeks, 4weeks
NDI-K questionnaire
Time frame: 4weeks
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 21 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Functional Dyspepsia
Active, not recruitingPhase 1
AutoSTEA for Adults With Functional Dyspepsia
Functional Dyspepsia
Recruiting
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing UI05MSP015CT and Gasmotin in people with Functional Dyspepsia, run by Korea United Pharm. Inc..
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 10 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 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change of symptom score of functional dyspepsia (time frame: 4weeks). 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 21 Jul 2017.