Status:
COMPLETED
A Comparison of Three Medications to Treat Diarrhea in Adults.
Lead Sponsor:
McNeil AB
Conditions:
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 s...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
415 Patients enrolled
Trial Details
Trial ID
NCT00807326
Start Date
November 1 2008
End Date
November 1 2009
Last Update
July 10 2012
Active Locations (6)
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1
Manipal Goa Hospital
Mormugao, Goa, India, 403004
2
Vrundavan Hospital & Research Centre
Mormugao, Goa, India, 403527
3
North West Medical
San José del Cabo, Baja California Sur, Mexico, 22447
4
Dr. Maxwell´s Clinic
San Miguel de Allende, Guanuajuato, Mexico, 37700