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This study aims to understand the effectiveness and safety of Motilium among study participants with dyspepsia-related symptoms in real-world settings in China.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall treatment effect (OTE) with "improved significantly" or "improved" | 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 | Day 3 |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jie Liu | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Overall treatment effect (OTE) with "improved significantly" or "improved" |
Proportion of participants who were classified as responders (OTE with "improved significantly" or "improved") on Day 7 or earlier if the treatment is < 7 days regardless of whether or not they were continuing use Motilium |
| Day 7 |
| Change in individual symptom GOS score≥ 2 | 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) | Day 3 and 7 |
| Time to change in Global Overall Symptom (GOS) ≥ 2 | Time to ≥ 2-point change in GOS score (ΔGOS) | Day 7 |
| Participants with improvement in GOS score | 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) | Day 3 and 7 |
| Participants with improvement in GOS score ≥ 2 | Proportion of participants with improvement in GOS score (ΔGOS) ≥ 2 and sustained without worsening for the rest of study period compared with baseline | Day 7 |
| Participants with improvement in individual symptoms using GOS score ≥ 2 | 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) | Day 7 |
| Positive feedback of the treatment | Proportion of participants who have positive satisfaction of treatment (Somewhat satisfied or Very satisfied) | Day 7 |
| Severity of AE and Serious Adverse Event (SAE) | Incidence and severity of AE and Serious Adverse Event (SAE) during the observational period | Day 7 |
| Took Motilium three times a day | Proportion of participants who took Motilium three times a day during treatment period | Day 7 |
| Took Motilium frequency | Proportion of participants who took Motilium for 1, 2, 3, 4, 5, 6, and 7 days | Day 7 |