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| ID | Type | Description | Link |
|---|---|---|---|
| R033812DYP4002 | Other Identifier | Xian-Janssen Pharmaceutical Ltd., China |
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The main purpose of the study is to assess the efficacy of domperidone in treatment of functional dyspepsia (FD) in Chinese participants and identify sub-populations (subtype of the disease) who are sensitive to domperidone treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Domperidone | Experimental | Participants will receive domperidone 10 milligram (mg) tablets orally thrice in a day from Day 1 to Day 14. |
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| Placebo | Placebo Comparator | Participants will receive matching placebo corresponding to domperidone orally thrice in a day from Day 1 to Day 14. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Domperidone | Drug | Participants will receive domperidone tablets orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Response Rate Based on Overall Treatment Effect (OTE) | Participants with overall symptoms extremely improved or improved will be considered as responders. Response rate of OTE is defined as the percentage (%) of responders in total participants. | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate Based on OTE | Participants with overall symptoms extremely improved or improved will be considered as responders. Response rate of OTE is defined as the percentage of responders in total participants. | Day 7 |
| Percentage of Participants with Each Average Symptom Score Decreased at least 2 Points Compared to Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xian-Janssen Pharmaceutical Ltd., China Clinical Trial | Xian-Janssen Pharmaceutical Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University, Beijing Friendship Hospital | Beijing | 100050 | China | |||
| Peking Union Medical College Hospital |
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| Label | URL |
|---|---|
| A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Prospective Pilot Study to Preliminarily Evaluate the Efficacy of Domperidone in Adult Chinese Subjects with Functional Dyspepsia | View source |
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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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| ID | Term |
|---|---|
| D004294 | Domperidone |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| Placebo | Drug | Participants will receive matching placebo to domperidone tablets orally. |
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Participants on every need will rate the severity of functional dyspepsia (FD) symptoms (postprandial fullness, early satiation, epigastric pain, epigastric burning, belching, epigastric bloating, nausea and vomiting) on a Likert scale of 7-point using e-diaries, the score range is 1 to 7. The higher the score, the more serious the outcome is.. For each FD symptom, the percentage of participants with each average symptom score (average of Day 1 through Day 7 and Day 8 through Day 14) decreased at least 2 points compared to baseline will be calculated. |
| Baseline, Day 1 to Day 7 and Day 8 to Day 14 |
| Change From Baseline in Frequency of Each FD Symptom | Participants on every need will rate the severity of functional dyspepsia (FD) symptoms (postprandial fullness, early satiation, epigastric pain, epigastric burning, belching, epigastric bloating, nausea and vomiting) on a Likert scale of 7-point using e-diaries, the score range is 1 to 7. The higher the score, the more serious the outcome is. | Baseline to Day 7 and Day 15 |
| Change from Baseline in Disease-Speciļ¬c Quality of Life (QoL) in FD as Assessed by Nepean Dyspepsia Index (NDI) Score | QoL will be assessed by using the NDI questionnaire. The NDI is a reliable and valid measure of quality of life in FD. The NDI originally contains 42 items designed to measure impairment of a subjective ability engaged in relevant aspects of their life because of dyspepsia. The score range is 0 to 100. The higher the score, the more serious the outcome is. | Baseline and Day 15 |
| Beijing |
| 100730 |
| China |
| Fujian Provincial Hospital | Fuzhou | 350001 | China |
| Union Hospital Tongji Medical College of Huazhong University of Science and Technology | Wuhan | 430022 | China |
| Tongji Hospital, Tongji Medical College of HUST | Wuhan | 430030 | China |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |