Exploratory Investigation of Motilium's Effectiveness and Safety for the OTC Treatment of Dyspepsia-related Symptoms
Completed
- Conditions
- Dyspepsia
- Registration Number
- NCT07028671
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness of Motilium 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 Day 7 To evaluate safety of treatments, based on adverse event (AE) reporting throughout the study period
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Motilium's therapeutic effects on functional dyspepsia in Chinese populations?
How does Motilium's efficacy for dyspepsia compare to standard-of-care agents like proton pump inhibitors in real-world settings?
Are there specific biomarkers in Chinese dyspepsia patients that correlate with Motilium treatment response in observational studies?
What adverse event profiles have been observed with Motilium use for dyspepsia in non-interventional clinical studies?
How do dopamine receptor antagonists like Motilium compare to other prokinetic agents in managing dyspepsia symptoms?
Trial Locations
- Locations (1)
Huashan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Huashan Hospital, Fudan University🇨🇳Shanghai, Shanghai, China