DyspepsiaPhase 2NCT02365701
Study of Motilitone to Treat Functional Dyspepsia
A Phase 2 study testing Motilitone 30mg in people with Dyspepsia, run by Dong-A ST Co., Ltd. at 1 site in United States.
Trial summary
This study is to evaluate efficacy of the investigational drug Motilitone at 90 mg in patients with Functional Dyspepsia as measured by change in maximum tolerated volume and aggregate symptom score on the nutrient drink test. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Motilitone 30mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Feb 2018
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Subject fulfilling Rome III criteria for Functional Dyspepsia: They must have one or more of the following:
- Bothersome postprandial fullness
- Early satiation
- Epigastric pain
- Epigastric burning AND No evidence of structural disease at upper endoscopy within last 3 months that is likely to explain the symptoms These must be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
- (2) At least a moderate or severe level within the previous 3 months for two of the following eight symptoms: upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiation, nausea, vomiting or excessive belching (each symptom rated as 0: None, 1: Mild, 2: Moderate, 3: Severe).
- (3) Subjects should be able to provide a written informed consent.
Who cannot join
- (1) Subject currently on medication for another study or who participated in another clinical trial or study within 4 weeks before the start of this study.
- (2) Women of childbearing potential who are not using contraception and pregnant or lactating women.
- (3) Subject who had surgery that may affect gastrointestinal motility.
- (4) Subject with known history of gastric bleeding, intestinal obstruction or perforation.
- (5) Subject with known history of celiac disease, inflammatory bowel disease (Crohn's disease, ulcerative colitis) or microscopic colitis.
- (6) Subject who had any of the diseases such as reflux esophagitis, gastroduodenal ulcer, gastric adenocarcinoma, esophageal adenocarcinoma, pancreatic disease, etc. that may be an organic cause of dyspepsia.
Show all 17Show fewer
- (7) Subject with liver dysfunction (serum glutamic oxaloacetic transaminase/serum glutamic pyruvic transaminase is at least 2.5 times higher than ULN).
- (8) Subject with renal dysfunction (Serum creatinine level is at least 1.5 times higher than ULN).
- (9) Subject with a serious cardiovascular (including known baseline QT prolongation defined by >450 msec) or respiratory illness.
- (10) Subject with diagnosed psychotic illnesses, substance dependence or alcoholism.
- (11) Subject currently taking drugs that may affect gastrointestinal motility (e.g., anticholinergic, Reglan, erythromycin, azithromycin, Domperidone, etc.), Buspirone, Acotiamide, Tramadol, nonsteroidal anti-inflammatory drug, systemic corticosteroids, and antidepressants, etc. within last 2 weeks of randomization.
- (12) Medications that can affect QT within last 2 weeks of randomization.
- (13) Subjects on herbal supplements for Functional Dyspepsia within last 2 weeks of randomization.
- (14) Subjects with gastric electric stimulator in place.
- (15) Subjects on narcotics or benzodiazepines within 7 days of randomization.
- (16) Subjects with score > 12 for anxiety or depression on the Hospital Anxiety and Depression Scale (HADS).
- (17) Vulnerable study population
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Placebo-controlled, Randomized, 4-week, Phase II Clinical Trial for Assessment of Efficacy and Safety of Motilitone in Patients With Functional Dyspepsia
This study is to evaluate efficacy of the investigational drug Motilitone at 90 mg in patients with Functional Dyspepsia as measured by change in maximum tolerated volume and aggregate symptom score on the nutrient drink test.
- Conditions
- Dyspepsia
- Being tested
- Motilitone 30mg, Placebo
- Keywords
- Functional Dyspepsia
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motilitone 30mgDrug
30mg of Motilitone in tablet form, to be taken 3 times daily for 4 weeks
PlaceboDrug
Placebo, in tablet form, to be taken 3 times daily for 4 weeks. The placebo is the same formulation as Motilitone except that it does not contain the active pharmaceutical ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Motilitone 30mg | Experimental | Motilitone will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 4 weeks. Receives: Drug: Motilitone 30mg |
| Placebo | Placebo comparator | Placebo (same formulation as Motilitone but without the active ingredients) will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this tablet for 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum tolerated volume by nutrient drink test
Measured: week -2, week 4
Change in aggregate symptom score by nutrient drink test
Measured: week -2, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Madhusudan Grover, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365701
- Sponsor's protocol ID
- Moti_FD_II
- Status last verified
- Jun 2018
- First submitted
- 5 Sep 2014
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled, Randomized, 4-week, Phase II Clinical Trial for Assessment of Efficacy and Safety of Motilitone in Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT02365701
- Acronym / sponsor ID
- Moti_FD_II
- Conditions
- Dyspepsia
- Keywords
- Functional Dyspepsia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 19 Feb 2015 (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 study is to evaluate efficacy of the investigational drug Motilitone at 90 mg in patients with Functional Dyspepsia as measured by change in maximum tolerated volume and aggregate symptom score on the nutrient drink test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motilitone 30mg | Experimental | Drug: Motilitone 30mgMotilitone will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 4 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (same formulation as Motilitone but without the active ingredients) will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this tablet for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- (1) Subject fulfilling Rome III criteria for Functional Dyspepsia: They must have one or more of the following:
- (2) At least a moderate or severe level within the previous 3 months for two of the following eight symptoms: upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiation, nausea, vomiting or excessive belching (each symptom rated as 0: None, 1: Mild, 2: Moderate, 3: Severe).
- (3) Subjects should be able to provide a written informed consent.
Key exclusion criteria (17 listed)
- (1) Subject currently on medication for another study or who participated in another clinical trial or study within 4 weeks before the start of this study.
- (2) Women of childbearing potential who are not using contraception and pregnant or lactating women.
- (3) Subject who had surgery that may affect gastrointestinal motility.
- (4) Subject with known history of gastric bleeding, intestinal obstruction or perforation.
- (5) Subject with known history of celiac disease, inflammatory bowel disease (Crohn's disease, ulcerative colitis) or microscopic colitis.
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 30mg30mg of Motilitone in tablet form, to be taken 3 times daily for 4 weeks | Drug | Motilitone 30mg |
| PlaceboPlacebo, in tablet form, to be taken 3 times daily for 4 weeks. The placebo is the same formulation as Motilitone except that it does not contain the active pharmaceutical ingredient. | Drug | Placebo |
Primary outcome
Change in maximum tolerated volume by nutrient drink test
Time frame: week -2, week 4
Change in aggregate symptom score by nutrient drink test
Time frame: week -2, week 4
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 May 2019.
Related trials for Dyspepsia
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Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
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Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
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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.
Madhusudan Grover, MBBS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motilitone 30mg in people with Dyspepsia, run by Dong-A ST Co., Ltd. at 1 site in United States.
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 7 inclusion and 17 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 May 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 in maximum tolerated volume by nutrient drink test (time frame: week -2, week 4). The study lists 2 primary outcomes in all. 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 May 2019.