Dyspepsia
Conditions
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.
Interventions
None listed
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to change in Global Overall Symptom (GOS) ≥ 2 | Day 7 | Time to ≥ 2-point change in GOS score (ΔGOS) |
| Participants with improvement in GOS score | Day 3 and 7 | Proportion of participants with a change in individual symptom GOS score (ΔGOS) ≥ 2 within first 3 days and first 7 days compared to baseline for each symptom (i.e., postprandial fullness, early satiation, epigastric pain, epigastric burning, belching, epigastric bloating, nausea, and vomiting) |
| Participants with improvement in GOS score ≥ 2 | Day 7 | Proportion of participants with improvement in GOS score (ΔGOS) ≥ 2 and sustained without worsening for the rest of study period compared with baseline |
| Participants with improvement in individual symptoms using GOS score ≥ 2 | Day 7 | Proportion of participants with improvement in individual symptoms using GOS score ≥ 2 and sustained without worsening for the rest of study period compared to baseline of that specific symptom (i.e., postprandial fullness, early satiation, epigastric pain, epigastric burning, belching, epigastric bloating, nausea, and vomiting) |
| Overall treatment effect (OTE) with improved significantly or improved | Day 3 | Proportion of participants who were classified as responders (overall treatment effect (OTE) with improved significantly or improved) on Day 3 or earlier if the treatment is \< 3 days regardless of whether or not they were continuing use Motilium |
| Severity of AE and Serious Adverse Event (SAE) | Day 7 | Incidence and severity of AE and Serious Adverse Event (SAE) during the observational period |
| Took Motilium three times a day | Day 7 | Proportion of participants who took Motilium three times a day during treatment period |
| Took Motilium frequency | Day 7 | Proportion of participants who took Motilium for 1, 2, 3, 4, 5, 6, and 7 days |
| Positive feedback of the treatment | Day 7 | Proportion of participants who have positive satisfaction of treatment (Somewhat satisfied or Very satisfied) |
| Change in individual symptom GOS score≥ 2 | Day 3 and 7 | Proportion of participants with a change in individual symptom GOS score (ΔGOS) ≥ 2 within first 3 days and first 7 days compared to baseline for each symptom (i.e., postprandial fullness, early satiation, epigastric pain, epigastric burning, belching, epigastric bloating, nausea, and vomiting) |
Countries
China
Outcome results
None listed