Clinical trial NCT00807326: A Comparison of Three Medications to Treat Diarrhea in Adults.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diarrhea
Keywords: Antidiarrheals
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of unformed stools
timeFrame: 0-24 hours
Secondary outcomes:
measure: Number of unformed stools
timeFrame: 0-12, 12-24, 24-36, 36-48 hours
measure: Time to last unformed stool
timeFrame: Throughout duration of the study
measure: Time to complete relief of abdominal discomfort
timeFrame: Throughout duration of the study
measure: Time to complete relief of diarrhea
timeFrame: Throughout duration of the study
measure: Proportion of subjects with complete relief of diarrhea
timeFrame: 4, 8, 12, 24 and 48 hours
measure: Gas-related abdominal discomfort ratings - change from baseline at subsequent time points
timeFrame: Throughout duration of the study
measure: Proportions of subjects with complete well-being
timeFrame: at 12, 24 and 48 hours.
measure: Subject's evaluation of treatment effectiveness for overall illness relief, diarrhea relief and abdominal discomfort relief
timeFrame: Throughout duration of the study
measure: Number of loperamide/simeticone 2 mg/125 mg caplets or chewable tablets or probiotic (Saccharomyces boulardii) 250 mg capsules used during the study
timeFrame: Throughout duration of the study
measure: Frequency of complete well-being following diarrhea illness
timeFrame: at 7 days follow up
measure: Stool frequency
timeFrame: at 7 days follow up
measure: Frequency of diarrhea relapse
timeFrame: at 7 days follow up
measure: 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.
timeFrame: throughout duration of the study (+ 30 days for spontaneously-reported SAEs)
Other outcomes:
Locations:
city: Goa
country: India
facility: Manipal Goa Hospital
city: Goa
country: India
facility: Vrundavan Hospital & Research Centre
city: San José del Cabo
country: Mexico
facility: North West Medical
state: Baja California Sur
city: San Miguel de Allende
country: Mexico
facility: Dr. Maxwell´s Clinic
state: Guanuajuato
city: Puerto Vallarta
country: Mexico
facility: Hospital Amerimed Puerto Vallarta
state: Jalisco
city: Puerto Vallarta
country: Mexico
facility: Servicios Medicos de la Bahia
state: Jalisco
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
citation: 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.