A Comparison of Three Medications to Treat Diarrhea in Adults.
NCT ID: NCT00807326
Last Updated: 2012-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
415 participants
INTERVENTIONAL
2008-11-30
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Loperamide/simeticone Caplets
Drug (including placebo)
Loperamide/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)
Loperamide/simeticone Chewable Tablets
Drug (including placebo)
Loperamide/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)
Probiotic Capsules
Drug (including placebo)
Probiotic 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)
Interventions
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Loperamide/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)
Loperamide/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)
Probiotic 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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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McNeil AB
INDUSTRY
Responsible Party
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Principal Investigators
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Elisabeth Kruse, PhD
Role: STUDY_DIRECTOR
McNeil AB
Locations
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Manipal Goa Hospital
Mormugao, Goa, India
Vrundavan Hospital & Research Centre
Mormugao, Goa, India
North West Medical
San José del Cabo, Baja California Sur, Mexico
Dr. Maxwell´s Clinic
San Miguel de Allende, Guanuajuato, Mexico
Hospital Amerimed Puerto Vallarta
Puerto Vallarta, Jalisco, Mexico
Servicios Medicos de la Bahia
Puerto Vallarta, Jalisco, Mexico
Countries
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References
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Cottrell J, Koenig K, Perfekt R, Hofmann R; Loperamide-Simethicone Acute Diarrhoea Study Team. Comparison of Two Forms of Loperamide-Simeticone and a Probiotic Yeast (Saccharomyces boulardii) in the Treatment of Acute Diarrhoea in Adults: A Randomised Non-Inferiority Clinical Trial. Drugs R D. 2015 Dec;15(4):363-73. doi: 10.1007/s40268-015-0111-y.
Other Identifiers
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LOPDIR4002
Identifier Type: -
Identifier Source: org_study_id