Diarrhea
Conditions
Keywords
Antidiarrheals
Brief summary
A comparison of three medications to treat diarrhea in adults.
Detailed description
This single (investigator) blind, randomized, 3-arm, parallel-group study design was selected to show non-inferiority of loperamide/simeticone caplets compared to chewable tablets in a heterogeneous subject population aiming at validity of results and reducing bias. The study will also compare the loperamide/simeticone combinations versus a probiotic (Saccharomyces boulardii) in the treatment of acute diarrhea in adults. Probiotics have been used for acute infectious diarrhea to reduce the duration and severity of the illness.
Interventions
DRUGLoperamide/simeticone 2 mg/125 mg caplets
Oral, 2 caplets taken initially at investigator site followed by one caplet after each unformed stool, maximum 4 caplets in a 24 hour period for a maximum of 48 hours (per product label)
DRUGLoperamide/simeticone 2 mg/125 mg chewable tablets
Oral, 2 chewable tablets taken initially at the site followed by one chewable tablet after each unformed stool, maximum 4 chewable tablets in a 24 hour period for a maximum of 48 hours (per product label)
DRUGProbiotic Saccharomyces boulardii 250 mg capsules
Oral, 1 capsule twice a day, maximum 2 capsules in a 24 hour period for a maximum of 5 days (per product label)
Sponsors
McNeil AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female at least 18 years of age * Acute diarrhea illness with symptoms onset within 48 hours of study entry * Minimum of 3 unformed stools in 24 hours before study entry * Most recent stool is unformed * Abdominal discomfort/wind (intensity mild to severe) within 4 hours of study entry * Women of childbearing potential must have a negative pregnancy test at screening * Willing to adhere to the prohibitions and restrictions specified in this protocol * Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion criteria
* Requiring hospital admission, parenteral hydration or antibiotic therapy Axillary temperature \>38.2°C or oral temperature \>38.6°C * History or clinical evidence of gross blood or pus in stool in current illness * Signs or symptoms of orthostatic hypotension * Unable to take medication and fluids by mouth * History of chronic gastrointestinal disease, hepatic or renal insufficiency, or other significant medical condition that could be aggravated by untreated acute diarrhea * Immunodeficiency (e.g. those with acquired immunodeficiency syndrome \[AIDS\] or known human immunodeficiency virus \[HIV\] infection, or undergoing chemotherapy or radiotherapy) * Intake of antibiotics, oral antifungals, quinidine or ritonavir within 7 days, antidiarrhoeal, promotility drugs (e.g., metoclopramide, domperidone), antiflatulents (e.g., simeticone, activated charcoal) or probiotics or bismuth salts within 48 hours, or any analgesic within 6 hours prior to study entry Hypersensitivity to loperamide, yeast, or any component of study formulations * Pregnant or breast-feeding * Unable to comply with the protocol requirements and schedule * Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study * Use of opiates (as 'recreational' drugs and as painkillers)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of unformed stools | 0-24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Time to last unformed stool | Throughout duration of the study |
| Time to complete relief of abdominal discomfort | Throughout duration of the study |
| Time to complete relief of diarrhea | Throughout duration of the study |
| Proportion of subjects with complete relief of diarrhea | 4, 8, 12, 24 and 48 hours |
| Gas-related abdominal discomfort ratings - change from baseline at subsequent time points | Throughout duration of the study |
| Proportions of subjects with complete well-being | at 12, 24 and 48 hours. |
| Number of unformed stools | 0-12, 12-24, 24-36, 36-48 hours |
| Number of loperamide/simeticone 2 mg/125 mg caplets or chewable tablets or probiotic (Saccharomyces boulardii) 250 mg capsules used during the study | Throughout duration of the study |
| Frequency of complete well-being following diarrhea illness | at 7 days follow up |
| Stool frequency | at 7 days follow up |
| Frequency of diarrhea relapse | at 7 days follow up |
| Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product. | throughout duration of the study (+ 30 days for spontaneously-reported SAEs) |
| Subject's evaluation of treatment effectiveness for overall illness relief, diarrhea relief and abdominal discomfort relief | Throughout duration of the study |
Countries
India, Mexico
Outcome results
None listed