Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence
Diarrhea
About this trial
This is an interventional treatment trial for Diarrhea focused on measuring Diarrhea, Flatulence, Abdominal discomfort, Loperamide hydrochloride, Simethicone, Placebo
Eligibility Criteria
Inclusion Criteria:
- Participant's symptoms of acute diarrhea must manifest within 48 hours prior to entering the trial
- Participant must have experienced at least three incidences of unformed stool within 24 hours prior to entering the trial (referring to any instances of watery stool or soft stool as determined after placing the stool in a container)
- Participant's most recently produced stool must be unformed stool
- Participant must give a positive answer to the following question: "Have you felt any abdominal discomfort caused by gastrointestinal gas accumulation within the last hour"
- Female participants must take effective contraceptive measures throughout the trial (including oral or injectable contraceptives, contraceptive tools, ligation) or be postmenopausal
Exclusion Criteria:
- Participant hospitalized for treatment of severe acute diarrhea or otherwise requires intravenous fluids or antibiotics on an outpatient basis
- Participant shows an axillary temperature greater than (>) 38.2 degrees Celsius (C) or an oral temperature > 38.6 degrees C
- Participant shows clinical symptoms of bloody or purulent stool or erythrocytes or leukocytes are detected in the participant's stool at > 3 per high power field
- Participant shows a sitting systolic blood pressure less than (<) 90 millimeter of mercury (mmHg) and/ or diastolic blood pressure < 60 mmHg
- Participant is unable to take medication orally or tolerate oral rehydration
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Loperamide Hydrochloride + Simethicone
Loperamide Hydrochloride
Participant will take 2 loperamide hydrochloride and simethicone chewable tablets + 2 loperamide hydrochloride placebo capsules orally, as their first dose, and subsequently 1 loperamide hydrochloride and simethicone chewable tablet + 1 loperamide hydrochloride placebo capsule orally, in the event of unformed stool (provided that no more than 4 tablets/capsules are taken within a 24-hour period) up to 48 hours.
Participant will take 2 loperamide hydrochloride capsules + 2 loperamide hydrochloride and simethicone chewable placebo tablets orally, as their first dose, and subsequently 1 loperamide hydrochloride capsule + 1 loperamide hydrochloride and simethicone chewable placebo tablet orally, in the event of unformed stool (provided that no more than 4 capsules/tablets are taken within a 24-hour period) up to 48 hours.