A Comparison of Three Medications to Treat Diarrhea in Adults.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT00807326
First received: December 9, 2008
Last updated: July 6, 2012
Last verified: July 2012

December 9, 2008
July 6, 2012
November 2008
August 2009   (final data collection date for primary outcome measure)
Number of unformed stools [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00807326 on ClinicalTrials.gov Archive Site
  • Number of unformed stools [ Time Frame: 0-12, 12-24, 24-36, 36-48 hours ] [ Designated as safety issue: No ]
  • Time to last unformed stool [ Time Frame: Throughout duration of the study ] [ Designated as safety issue: No ]
  • Time to complete relief of abdominal discomfort [ Time Frame: Throughout duration of the study ] [ Designated as safety issue: No ]
  • Time to complete relief of diarrhea [ Time Frame: Throughout duration of the study ] [ Designated as safety issue: No ]
  • Proportion of subjects with complete relief of diarrhea [ Time Frame: 4, 8, 12, 24 and 48 hours ] [ Designated as safety issue: No ]
  • Gas-related abdominal discomfort ratings - change from baseline at subsequent time points [ Time Frame: Throughout duration of the study ] [ Designated as safety issue: No ]
  • Proportions of subjects with complete well-being [ Time Frame: at 12, 24 and 48 hours. ] [ Designated as safety issue: No ]
  • Subject's evaluation of treatment effectiveness for overall illness relief, diarrhea relief and abdominal discomfort relief [ Time Frame: Throughout duration of the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Frequency of complete well-being following diarrhea illness [ Time Frame: at 7 days follow up ] [ Designated as safety issue: No ]
  • Stool frequency [ Time Frame: at 7 days follow up ] [ Designated as safety issue: No ]
  • Frequency of diarrhea relapse [ Time Frame: at 7 days follow up ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

A comparison of three medications to treat diarrhea in adults.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Diarrhea
  • 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
  • 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
  • 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
  • Experimental: Loperamide/simeticone Caplets
    Drug (including placebo)
    Intervention: Drug: Loperamide/simeticone 2 mg/125 mg caplets
  • Active Comparator: Loperamide/simeticone Chewable Tablets
    Drug (including placebo)
    Intervention: Drug: Loperamide/simeticone 2 mg/125 mg chewable tablets
  • Active Comparator: Probiotic Capsules
    Drug (including placebo)
    Intervention: Drug: Probiotic Saccharomyces boulardii 250 mg capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
415
November 2009
August 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India,   Mexico
 
NCT00807326
LOPDIR4002
No
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
McNeil AB
Not Provided
Study Director: Elisabeth Kruse, PhD McNeil AB
Johnson & Johnson Consumer and Personal Products Worldwide
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP