Exploratory Investigation of Motilium's Effectiveness and Safety for the OTC Treatment of Dyspepsia-related Symptoms

NCT ID: NCT07028671

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-28
• Study Completion Date: 2024-03-26

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.

Conditions

Dyspepsia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jie Liu

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

R033812GAI4001

Identifier Type: -

Identifier Source: org_study_id