DyspepsiaPhase 4NCT03617016
Preliminarily Evaluate the Efficacy of Domperidone in Adult Chinese Participants With Functional Dyspepsia
A Phase 4 study testing Domperidone in people with Dyspepsia, run by Xian-Janssen Pharmaceutical Ltd. at 5 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Domperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 5 sitesChina
- Study dates
- 27 Aug 2018to 31 Jul 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must meet the diagnostic criteria for functional dyspepsia (Postprandial Distress Syndrome [PDS] and/or Epigastric Pain Syndrome [EPS]) according to Rome IV diagnostic criteria for functional gastrointestinal disorders before and through screening
- Must have had an upper endoscopy that shows no evidence of structural change that is likely to explain the dyspepsia symptoms. If the participant has had the upper endoscopy performed within 3 months before screening, no re-test is needed
- Must have an abdominal ultrasonography that shows no evidence of organic disease that is likely to explain the dyspepsia symptoms. If the participant has the abdominal ultrasonography performed within 3 months before screening, no re-test is needed
- A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [beta-hCG]) pregnancy test at Screening
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 30 days after receiving the last dose of study drug
- Otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents and signed by the investigator. Specifically, for vital signs, the participant must have blood pressure (after participant has been supine for 10 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic (inclusive) and between 60 and 90 mmHg diastolic (inclusive)
Who cannot join
- Has a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease (including bronchospastic respiratory disease), diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Has history of risk factors for Torsade de Pointes or family history of short QT syndrome, long QT syndrome, sudden unexplained death at a young age (less than or equal to [<=] 40 years); or a history of second- or third-degree heart block
- Has clinically significant electrolyte disorders or conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings
- Has a history of esophageal, gastric, or duodenal surgery, including endoscopic surgery
- Has any condition in which stimulation of gastric motility might be dangerous, for example (e.g.), in the presence of gastrointestinal (GI) hemorrhage, mechanical obstruction, or perforation
- Has used any of the following medications 7 days before screening: proton pump inhibitors, antacids, anti-secretory agents, histamine2 receptor antagonists, gastric mucosa protective agents, digestive enzymes, prokinetic agents (including macrolide antibiotics), and other drugs that affect gastrointestinal function, QT-prolonging drugs, cytochrome P450 3A4 inhibitors, monoamine oxidase inhibitors (MAOIs), nonsteroidal anti-inflammatory agents, aspirin (including low-dose aspirin), anticholinergics, antidepressants, or diuretics
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Capital Medical University, Beijing Friendship Hospital
Beijing, 100050
Peking Union Medical College Hospital
Beijing, 100730
Fujian Provincial Hospital
Fuzhou, 350001
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430022
Tongji Hospital, Tongji Medical College of HUST
Wuhan, 430030
About this study
Official title: 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
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.
- Conditions
- Dyspepsia
- Being tested
- Domperidone, Placebo
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomperidoneDrug
Also called JNJ-17296812
Participants will receive domperidone tablets orally.
PlaceboDrug
Participants will receive matching placebo to domperidone tablets orally.
| Study group | Role | What they receive |
|---|---|---|
| Domperidone | Experimental | Participants will receive domperidone 10 milligram (mg) tablets orally thrice in a day from Day 1 to Day 14. Receives: Drug: Domperidone |
| Placebo | Placebo comparator | Participants will receive matching placebo corresponding to domperidone orally thrice in a day from Day 1 to Day 14. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 14
Secondary outcomes (4)
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.
Measured: Day 7
Percentage of Participants with Each Average Symptom Score Decreased at least 2 Points Compared to Baseline
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.
Measured: 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.
Measured: Baseline to Day 7 and Day 15
Change from Baseline in Disease-Specific 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.
Measured: Baseline and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start27 Aug 2018
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xian-Janssen Pharmaceutical Ltd., China Clinical Trial, Study director, Xian-Janssen Pharmaceutical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617016
- Sponsor's protocol ID
- CR108512
- Other IDs
- R033812DYP4002
- Status last verified
- Apr 2025
- First submitted
- 10 Jul 2018
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03617016
- Acronym / sponsor ID
- CR108512
- Conditions
- Dyspepsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Domperidone | Experimental | Drug: DomperidoneParticipants will receive domperidone 10 milligram (mg) tablets orally thrice in a day from Day 1 to Day 14. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo corresponding to domperidone orally thrice in a day from Day 1 to Day 14. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Must meet the diagnostic criteria for functional dyspepsia (Postprandial Distress Syndrome [PDS] and/or Epigastric Pain Syndrome [EPS]) according to Rome IV diagnostic criteria for functional gastrointestinal disorders before and through screening
- Must have had an upper endoscopy that shows no evidence of structural change that is likely to explain the dyspepsia symptoms. If the participant has had the upper endoscopy performed within 3 months before screening, no re-test is needed
- Must have an abdominal ultrasonography that shows no evidence of organic disease that is likely to explain the dyspepsia symptoms. If the participant has the abdominal ultrasonography performed within 3 months before screening, no re-test is needed
- A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [beta-hCG]) pregnancy test at Screening
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 30 days after receiving the last dose of study drug
Key exclusion criteria (6 listed)
- Has a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease (including bronchospastic respiratory disease), diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Has history of risk factors for Torsade de Pointes or family history of short QT syndrome, long QT syndrome, sudden unexplained death at a young age (less than or equal to [<=] 40 years); or a history of second- or third-degree heart block
- Has clinically significant electrolyte disorders or conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings
- Has a history of esophageal, gastric, or duodenal surgery, including endoscopic surgery
- Has any condition in which stimulation of gastric motility might be dangerous, for example (e.g.), in the presence of gastrointestinal (GI) hemorrhage, mechanical obstruction, or perforation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DomperidoneAlso: JNJ-17296812Participants will receive domperidone tablets orally. | Drug | Domperidone |
| PlaceboParticipants will receive matching placebo to domperidone tablets orally. | Drug | Placebo |
Primary outcome
Response Rate Based on Overall Treatment Effect (OTE)
Time frame: Day 14
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.
4 secondary outcomes
Response Rate Based on OTE
Time frame: Day 7
Percentage of Participants with Each Average Symptom Score Decreased at least 2 Points Compared to Baseline
Time frame: Baseline, Day 1 to Day 7 and Day 8 to Day 14
Change From Baseline in Frequency of Each FD Symptom
Time frame: Baseline to Day 7 and Day 15
Change from Baseline in Disease-Specific Quality of Life (QoL) in FD as Assessed by Nepean Dyspepsia Index (NDI) Score
Time frame: Baseline and Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- 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 DyspepsiaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xian-Janssen Pharmaceutical Ltd., China Clinical Trial study director
Xian-Janssen Pharmaceutical Ltd.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Domperidone in people with Dyspepsia, run by Xian-Janssen Pharmaceutical Ltd. at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate Based on Overall Treatment Effect (OTE) (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.