DyspepsiaNCT07028671
Exploratory Investigation of Motilium's Effectiveness and Safety for the OTC Treatment of Dyspepsia-related Symptoms
An observational study of Dyspepsia, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in China.
Trial summary
This study aims to understand the effectiveness and safety of Motilium among study participants with dyspepsia-related symptoms in real-world settings in China. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dyspepsia
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2023to 26 Mar 2024
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Study participant recruitment will occur at retail pharmacies in different provinces across China. Consumers assessed in this study are adult participants who purchase OTC Motilium at pharmacies to treat dyspepsia-related symptoms in China. Consumers who fulfill the pre-defined inclusion and exclusion criterion and sign the informed consent form are study participants. The decision of individuals to participate in this study must not, in any way, impact upon the standard of care that they are receiving or any benefits to which they are otherwise entitled. The treatment decision must have been taken prior to and independently of the patient's inclusion in the study.
Who may be able to join
- Individuals purchased OTC Motilium at pharmacies for themselves for the treatment of one or more dyspepsia-related symptoms including postprandial fullness, early satiation, epigastric pain, epigastric burning, belching, epigastric bloating, nausea, and vomiting
- Provided signed and dated informed consent
Who cannot join
- Individuals who suffered from dyspepsia-related symptoms ≥ 3 days/week for at least 3 months prior to joining the study
- Individuals who suffered exclusively from heartburn
- Individuals taking or planning to take dyspepsia-related medication, including but not limited to proton pump inhibitors, hydrotalcite, Talcid, Sanjiu Weitai, JianWeiXiaoShiPian, Jiangzhong Jianwei, Digestive enzyme, Itopride, Mosapride, and Famotidine
- History of, or current, cardiac disease or cardiac arrhythmias including QT prolongation, ventricular tachycardia, ventricular fibrillation and Torsades de Pointes
- Any of the following warning signs: black stool, unintended weight loss, progressive dysphagia, persistent vomiting, abdominal mass, and fever
- Diagnosed with accompanying GI or other disease (e.g., GI tumors, peptic ulcer, and hiatal hernia)
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- Conditions with elevated health risk if having increased gastric motility (e.g., GI hemorrhage, mechanical obstruction or perforation)
- Hepatic dysfunction and renal insufficiency
- Concomitant use with oral ketoconazole, erythromycin, or other potent inhibitors of CYP3A4 enzymes that may prolong the QTc interval (refer to Chinese OTC label. e.g., fluconazole, voriconazole, clarithromycin, amiodarone, telithromycin, itraconazole, posaconazole, ritonavir, saquinavir, and telaprevir)
- Known allergies to Motilium (domperidone) or any other ingredient of Motilium
- Pregnant, breast feeding female or planning to become pregnant (either potential participant or potential participant's partner)
- Individuals who are currently taking Motilium
- Individuals who did not get relieved from dyspepsia-related symptoms after taking Motilium
- Individuals participating in any other clinical trials during this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Pilot Investigation of Motilium's Effectiveness and Safety for the OTC Treatment of Dyspepsia-related Symptoms Among Chinese Suffers Using Real-world Evidence: A Non-interventional, Prospective, Observational Study
This study aims to understand the effectiveness and safety of Motilium among study participants with dyspepsia-related symptoms in real-world settings in China.
- Conditions
- Dyspepsia
- Medical subject headings
- Dyspepsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Motilium
To evaluate the effectiveness of Motilium for treating dyspepsia-related symptoms among adult study participants who purchase OTC Motilium in China
Measured: Day 7
Safety of Motilium
To evaluate safety of treatments, based on adverse event (AE) reporting throughout the study period
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start28 Dec 2023
- Primary completion26 Mar 2024
- Study completion26 Mar 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Liu, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028671
- Sponsor's protocol ID
- R033812GAI4001
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Pilot Investigation of Motilium's Effectiveness and Safety for the OTC Treatment of Dyspepsia-related Symptoms Among Chinese Suffers Using Real-world Evidence: A Non-interventional, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT07028671
- Acronym / sponsor ID
- R033812GAI4001
- Conditions
- Dyspepsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 19 Jun 2025 (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 aims to understand the effectiveness and safety of Motilium among study participants with dyspepsia-related symptoms in real-world settings in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Study participant recruitment will occur at retail pharmacies in different provinces across China. Consumers assessed in this study are adult participants who purchase OTC Motilium at pharmacies to treat dyspepsia-related symptoms in China. Consumers who fulfill the pre-defined inclusion and exclusion criterion and sign the informed consent form are study participants. The decision of individuals to participate in this study must not, in any way, impact upon the standard of care that they are receiving or any benefits to which they are otherwise entitled. The treatment decision must have been taken prior to and independently of the patient's inclusion in the study.
Key inclusion criteria (2 listed)
- Individuals purchased OTC Motilium at pharmacies for themselves for the treatment of one or more dyspepsia-related symptoms including postprandial fullness, early satiation, epigastric pain, epigastric burning, belching, epigastric bloating, nausea, and vomiting
- Provided signed and dated informed consent
Key exclusion criteria (14 listed)
- Individuals who suffered from dyspepsia-related symptoms ≥ 3 days/week for at least 3 months prior to joining the study
- Individuals who suffered exclusively from heartburn
- Individuals taking or planning to take dyspepsia-related medication, including but not limited to proton pump inhibitors, hydrotalcite, Talcid, Sanjiu Weitai, JianWeiXiaoShiPian, Jiangzhong Jianwei, Digestive enzyme, Itopride, Mosapride, and Famotidine
- History of, or current, cardiac disease or cardiac arrhythmias including QT prolongation, ventricular tachycardia, ventricular fibrillation and Torsades de Pointes
- Any of the following warning signs: black stool, unintended weight loss, progressive dysphagia, persistent vomiting, abdominal mass, and fever
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness of Motilium
Time frame: Day 7
To evaluate the effectiveness of Motilium for treating dyspepsia-related symptoms among adult study participants who purchase OTC Motilium in China
Safety of Motilium
Time frame: Day 7
To evaluate safety of treatments, based on adverse event (AE) reporting throughout the study period
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 19 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Jie Liu principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspepsia, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in China.
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 2 inclusion and 14 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 19 Jun 2025. 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 China. 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?
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?
Effectiveness of Motilium (time frame: Day 7). 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 19 Jun 2025.