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CompletedNCT00807326Updated Jul 10, 2012

A Comparison of Three Medications to Treat Diarrhea in Adults.

A Phase 4 interventional study of Loperamide/simeticone 2 mg/125 mg caplets and Loperamide/simeticone 2 mg/125 mg chewable tablets in Diarrhea, sponsored by McNeil AB. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-10.

Sponsored by McNeil AB · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
415
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

A comparison of three medications to treat diarrhea in adults.

Read the 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.

02

Conditions studied

  • Diarrhea

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Keywords

  • Antidiarrheals
03

In context

Diarrhea

852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.

This study's enrollment of 415 is above the median of 136 across 713 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

McNeil AB is the lead sponsor of 41 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
415 participants (actual)

Study arms

  • Experimental
    Loperamide/simeticone Caplets

    Drug (including placebo)

    Drug: Loperamide/simeticone 2 mg/125 mg caplets

  • Active comparator
    Loperamide/simeticone Chewable Tablets

    Drug (including placebo)

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

  • Active comparator
    Probiotic Capsules

    Drug (including placebo)

    Drug: Probiotic Saccharomyces boulardii 250 mg capsules

Interventions

  • DrugLoperamide/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)

    Also known as: Imodium® Plus Caplet

  • DrugLoperamide/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)

    Also known as: Imodium® Plus Chewable tablet

  • DrugProbiotic 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)

    Also known as: Perenterol® Forte 250mg capsules

06

What researchers measure

Primary outcomes

  1. Number of unformed stools

    Time frame: 0-24 hours

Secondary outcomes

  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)

07

Study locations

6 sites
  • Manipal Goa Hospital
    Goa, 403004, India
  • Vrundavan Hospital & Research Centre
    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
08

References and documents

Publications

  • 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. PubMed 26541878 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00807326
Lead sponsor
McNeil AB
Responsible party
Sponsor
First posted
Dec 11, 2008
Start date
Nov 2008
Primary completion
Aug 2009
Completion
Nov 2009
Last update
Jul 10, 2012

Study contacts

Elisabeth Kruse, PhD
study director · McNeil AB

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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