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A Comparison of Three Medications to Treat Diarrhea in Adults.

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ClinicalTrials.gov Identifier: NCT00807326
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : July 10, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
A comparison of three medications to treat diarrhea in adults.

Condition or disease Intervention/treatment Phase
Diarrhea Drug: Loperamide/simeticone 2 mg/125 mg caplets Drug: Loperamide/simeticone 2 mg/125 mg chewable tablets Drug: Probiotic Saccharomyces boulardii 250 mg capsules Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 415 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : November 2008
Primary Completion Date : August 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Loperamide/simeticone Caplets
Drug (including placebo)
Drug: 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)
Other Name: Imodium® Plus Caplet
Active Comparator: Loperamide/simeticone Chewable Tablets
Drug (including placebo)
Drug: 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)
Other Name: Imodium® Plus Chewable tablet
Active Comparator: Probiotic Capsules
Drug (including placebo)
Drug: 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 Name: Perenterol® Forte 250mg capsules

Outcome Measures

Primary Outcome Measures :
  1. Number of unformed stools [ Time Frame: 0-24 hours ]

Secondary Outcome Measures :
  1. Number of unformed stools [ Time Frame: 0-12, 12-24, 24-36, 36-48 hours ]
  2. Time to last unformed stool [ Time Frame: Throughout duration of the study ]
  3. Time to complete relief of abdominal discomfort [ Time Frame: Throughout duration of the study ]
  4. Time to complete relief of diarrhea [ Time Frame: Throughout duration of the study ]
  5. Proportion of subjects with complete relief of diarrhea [ Time Frame: 4, 8, 12, 24 and 48 hours ]
  6. Gas-related abdominal discomfort ratings - change from baseline at subsequent time points [ Time Frame: Throughout duration of the study ]
  7. Proportions of subjects with complete well-being [ Time Frame: at 12, 24 and 48 hours. ]
  8. Subject's evaluation of treatment effectiveness for overall illness relief, diarrhea relief and abdominal discomfort relief [ Time Frame: Throughout duration of the study ]
  9. Number of loperamide/simeticone 2 mg/125 mg caplets or chewable tablets or probiotic (Saccharomyces boulardii) 250 mg capsules used during the study [ Time Frame: Throughout duration of the study ]
  10. Frequency of complete well-being following diarrhea illness [ Time Frame: at 7 days follow up ]
  11. Stool frequency [ Time Frame: at 7 days follow up ]
  12. Frequency of diarrhea relapse [ Time Frame: at 7 days follow up ]
  13. 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. [ Time Frame: throughout duration of the study (+ 30 days for spontaneously-reported SAEs) ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807326

Manipal Goa Hospital
Goa, India, 403004
Vrundavan Hospital & Research Centre
Goa, India, 403527
North West Medical
San José del Cabo, Baja California Sur, Mexico, 22447
Dr. Maxwell´s Clinic
San Miguel de Allende, Guanuajuato, Mexico, 37700
Hospital Amerimed Puerto Vallarta
Puerto Vallarta, Jalisco, Mexico, 48300
Servicios Medicos de la Bahia
Puerto Vallarta, Jalisco, Mexico, 48300
Sponsors and Collaborators
McNeil AB
Study Director: Elisabeth Kruse, PhD McNeil AB
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: McNeil AB
ClinicalTrials.gov Identifier: NCT00807326     History of Changes
Other Study ID Numbers: LOPDIR4002
First Posted: December 11, 2008    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB ):

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Agents
Antifoaming Agents
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents