A Comparison of Three Medications to Treat Diarrhea in Adults.
A Randomized, Parallel Group Comparison of Loperamide/Simeticone Caplet, Loperamide/Simeticone Chewable Tablet (IMODIUM® PLUS) and a Probiotic (Saccharomyces Boulardii) in the Treatment of Acute Diarrhea in Adults
1 other identifier
interventional
415
2 countries
6
Brief Summary
A comparison of three medications to treat diarrhea in adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2008
Shorter than P25 for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 9, 2008
CompletedFirst Posted
Study publicly available on registry
December 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedJuly 10, 2012
July 1, 2012
9 months
December 9, 2008
July 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of unformed stools
0-24 hours
Secondary Outcomes (13)
Number of unformed stools
0-12, 12-24, 24-36, 36-48 hours
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
- +8 more secondary outcomes
Study Arms (3)
Loperamide/simeticone Caplets
EXPERIMENTALDrug (including placebo)
Loperamide/simeticone Chewable Tablets
ACTIVE COMPARATORDrug (including placebo)
Probiotic Capsules
ACTIVE COMPARATORDrug (including placebo)
Interventions
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)
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)
Oral, 1 capsule twice a day, maximum 2 capsules in a 24 hour period for a maximum of 5 days (per product label)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McNeil ABlead
Study Sites (6)
Manipal Goa Hospital
Mormugao, Goa, 403004, India
Vrundavan Hospital & Research Centre
Mormugao, Goa, 403527, India
North West Medical
San José del Cabo, Baja California Sur, 22447, Mexico
Dr. Maxwell´s Clinic
San Miguel de Allende, Guanuajuato, 37700, Mexico
Hospital Amerimed Puerto Vallarta
Puerto Vallarta, Jalisco, 48300, Mexico
Servicios Medicos de la Bahia
Puerto Vallarta, Jalisco, 48300, Mexico
Related Publications (1)
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.
PMID: 26541878DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elisabeth Kruse, PhD
McNeil AB
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2008
First Posted
December 11, 2008
Study Start
November 1, 2008
Primary Completion
August 1, 2009
Study Completion
November 1, 2009
Last Updated
July 10, 2012
Record last verified: 2012-07