Acute gastroenteritis
Conditions
Interventions
A single, oral dose of PEDON or Placebo will be administered. Subjects who vomit after the initial dose and return to the study site may receive an additional dose of the investigational drug (PEDON)
Sponsors
Kishibe Shun
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Clinically diagnosed with acute gastroenteritis. (2) After the onset of acute gastroenteritis, has vomited at least twice within 24 hours before the start of medical examination performed prior to informed consent. (3) After the onset of acute gastroenteritis, has vomited at least once within 4 hours before the start of medical examination performed prior to informed consent. (4) Japanese children (female and male) aged >= 6 months to < 15 years at the time of informed consent. (5) Has provided written informed consent through their legally acceptable representative (parent). (6) For those aged 7 years and older, has received an explanation using an assent document and has provided written informed assent to the extent possible.
Exclusion criteria
Exclusion criteria: (1) Has experienced biliary or bloody vomiting. (2) Is currently receiving treatment for hypertension and/or diabetes. (3) Has clinical suspected infection outside the gastrointestinal tract (e.g., pneumonia, urinary tract infection, meningitis, otitis media acute). However, those with symptoms of acute gastroenteritis associated with influenza virus, SARS-CoV-2, or adenovirus that have been confirmed by testing or diagnosed by a physician may be eligible for enrollment. (4) After the onset of acute gastroenteritis, has received antiemetics within 72 hours before the start of medical examination performed prior to informed consent. (5) Weighs less than 7 kg. (6) Has participated in another clinical study and received a study drug within 3 months prior to informed consent, or is scheduled to participate in another clinical study before the completion of this study. (7) Has hypersensitivity to ondansetron (8) Has serious dehydration or hypoglycaemia requiring bolus infusion. (9) Has clinically suspected non-communicable diseases (e.g., inflammatory bowel disease, intussusception, drug-induced diarrhoea, acute appendicitis, or surgical conditions such as intestinal obstruction). (10) Has a complication or history of severe cardiovascular, respiratory, endocrine, gastrointestinal, renal or urological, hematological, neurological, or psychiatric disease that, in the opinion of the principal (or sub-) investigator, may interfere with participation in the study. (11) Is pregnant or may be pregnant. (12) Has a history of abdominal surgery. (13) Exhibits symptoms of gastrointestinal obstruction. (14) Has serious hepatic impairment. (15) Has a complication or history of malignancy. (16) Has a history of epilepsy. (17) Has experienced disturbance of consciousness. (18) Has drug intoxication. (19) Has previously enrolled in this study. (20) Has previously received ondansetron products. (21) Has been determined by the principal (or sub-) investigator to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects whose vomiting has resolved for 4 hours after administration of the study drug (investigational drug or control drug), compared between the investigational drug group and the control group) | — |
Secondary
| Measure | Time frame |
|---|---|
| The investigational drug group and the control group are compared for the following endpoints: -Proportion of subjects whose vomiting has resolved for 8 hours after study drug administration (excluding subjects who received an additional dose after 4 hours post-administration) -Time to first vomiting episode after study drug administration -Duration of vomiting (time from study drug administration to last vomiting episode) -Number of vomiting episodes (at 4 hours and 8 hours after study drug administration) -Proportion of subjects requiring IV fluids (at 4 hours and 8 hours after study drug administration, and Day 8) -Proportion of subjects requiring hospitalization (at 4 hours and 8 hours after study drug administration; Day 8) -NRS (Numerical Rating Scale, 0-10 scale) for nausea (before study drug administration; at 1, 4, 24 hours after study drug administration; Day 3 to Day 8) (for subjects aged >= 6 years) -Duration of nausea (number of days from study drug administration until NRS value reaches 0) -Status of water intake (at 4 hours after study drug administration) -Number of days until resolution (i.e., recovery) of all acute gastroenteritis symptoms | — |
Contacts
Public ContactDevelopment Department R & D Division
Miyarisan Pharmaceutical Co., Ltd.
Outcome results
None listed