A Comparison of Three Medications to Treat Diarrhea in Adults.

McNeil-PPC

Status and phase: Completed; Phase 4

Conditions: Diarrhea

Treatments: Drug: Loperamide/simeticone 2 mg/125 mg chewable tablets; Drug: Loperamide/simeticone 2 mg/125 mg caplets; Drug: Probiotic Saccharomyces boulardii 250 mg capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT00807326

LOPDIR4002

Details and patient eligibility

About

A comparison of three medications to treat diarrhea in adults.

Full 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.

Enrollment: 415 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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415 participants in 3 patient groups

Loperamide/simeticone Caplets

Experimental group

Description:

Drug (including placebo)

Treatment:

Drug: Loperamide/simeticone 2 mg/125 mg caplets

Loperamide/simeticone Chewable Tablets

Active Comparator group

Description:

Drug (including placebo)

Treatment:

Drug: Loperamide/simeticone 2 mg/125 mg chewable tablets

Probiotic Capsules

Active Comparator group

Description:

Drug (including placebo)

Treatment:

Drug: Probiotic Saccharomyces boulardii 250 mg capsules