Domperidone
DrugParticipants will receive domperidone tablets orally.
Other names: JNJ-17296812
NCT Number: NCT03617016
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.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Phase 4
Capital Medical University, Beijing Friendship Hospital, Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive domperidone tablets orally.
Other names: JNJ-17296812
Participants will receive matching placebo to domperidone tablets orally.
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.
Time frame: Day 7
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.
Time frame: Baseline, Day 1 to Day 7 and Day 8 to Day 14
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.
Time frame: Baseline to Day 7 and Day 15
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.
Time frame: Baseline and Day 15
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.
Xian-Janssen Pharmaceutical Ltd.
Industry
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
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.
Published trials that share one or more normalized conditions with this study.
NCT05810168
Digestive System Diseases, Dyspepsia
Sheffield, South Yorkshire, United Kingdom
View Trial DetailsNCT05004012
Digestive System Diseases, Dyspepsia
Los Angeles, California, United States
View Trial DetailsNCT06760897
Dysbiosis, Dyspepsia
Guangzhou, Guangdong, China
View Trial DetailsNCT06150638
Colonic Diseases, Colonic Diseases, Functional
Barcelona, Spain
View Trial Details