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Completed

NCT Number: NCT07028671

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

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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Key information

Conditions

Dyspepsia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Effectiveness of Motilium

    Time frame: Day 7

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

  2. Safety of Motilium

    Time frame: Day 7

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

Other outcomes

  1. Overall treatment effect (OTE) with "improved significantly" or "improved"

    Time frame: 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

  2. Overall treatment effect (OTE) with "improved significantly" or "improved"

    Time frame: Day 7

    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

  3. Change in individual symptom GOS score≥ 2

    Time frame: 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)

  4. Time to change in Global Overall Symptom (GOS) ≥ 2

    Time frame: Day 7

    Time to ≥ 2-point change in GOS score (ΔGOS)

  5. Participants with improvement in GOS score

    Time frame: 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)

  6. Participants with improvement in GOS score ≥ 2

    Time frame: 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

  7. Participants with improvement in individual symptoms using GOS score ≥ 2

    Time frame: 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)

  8. Positive feedback of the treatment

    Time frame: Day 7

    Proportion of participants who have positive satisfaction of treatment (Somewhat satisfied or Very satisfied)

  9. Severity of AE and Serious Adverse Event (SAE)

    Time frame: Day 7

    Incidence and severity of AE and Serious Adverse Event (SAE) during the observational period

  10. Took Motilium three times a day

    Time frame: Day 7

    Proportion of participants who took Motilium three times a day during treatment period

  11. Took Motilium frequency

    Time frame: Day 7

    Proportion of participants who took Motilium for 1, 2, 3, 4, 5, 6, and 7 days

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

Industry

Registry information

Official study title

Exploratory Pilot Investigation of Motilium's Effectiveness and Safety for the OTC Treatment of Dyspepsia-related Symptoms Among Chinese Suffers Using Real-world Evidence: A Non-interventional, Prospective, Observational Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 19, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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