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

NCT07028671 | Completed

• 1 other identifier: R033812GAI4001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Effectiveness of Motilium

  To evaluate the effectiveness of Motilium for treating dyspepsia-related symptoms among adult study participants who purchase OTC Motilium in China

  Day 7

• Safety of Motilium

  To evaluate safety of treatments, based on adverse event (AE) reporting throughout the study period

  Day 7

Other Outcomes (11)

• Overall treatment effect (OTE) with "improved significantly" or "improved"

  Day 3

• Overall treatment effect (OTE) with "improved significantly" or "improved"

  Day 7

• Change in individual symptom GOS score≥ 2

  Day 3 and 7

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jie Liu

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: December 28, 2023
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)