Preliminarily Evaluate the Efficacy of Domperidone in Adult Chinese Participants With Functional Dyspepsia

NCT03617016 | Completed Phase 4

• 2 other identifiers: CR108512R033812DYP4002
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Response Rate Based on OTE

  Day 7

• Percentage of Participants with Each Average Symptom Score Decreased at least 2 Points Compared to Baseline

  Baseline, Day 1 to Day 7 and Day 8 to Day 14

• Change From Baseline in Frequency of Each FD Symptom

  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

  Baseline and Day 15

Study Arms (2)

Domperidone

EXPERIMENTAL

Participants will receive domperidone 10 milligram (mg) tablets orally thrice in a day from Day 1 to Day 14.

Drug: Domperidone

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo corresponding to domperidone orally thrice in a day from Day 1 to Day 14.

Drug: Placebo

Interventions

Domperidone DRUG

Participants will receive domperidone tablets orally.

Also known as: JNJ-17296812

Domperidone

Placebo DRUG

Participants will receive matching placebo to domperidone tablets orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Study Sites (5)

Capital Medical University, Beijing Friendship Hospital

Beijing, 100050, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Fujian Provincial Hospital

Fuzhou, 350001, China

Location

Union Hospital Tongji Medical College of Huazhong University of Science and Technology

Wuhan, 430022, China

Location

Tongji Hospital, Tongji Medical College of HUST

Wuhan, 430030, China

Location

Related Links

• 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

MeSH Terms

Conditions

Dyspepsia

Interventions

Domperidone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 6, 2018
• Study Start: August 27, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

CN (5)