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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
History of Changes
  Purpose

A comparison of three medications to treat diarrhea in adults.


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Number of unformed stools [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 415
Study Start Date: November 2008
Study Completion Date: November 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807326

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

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT00807326     History of Changes
Other Study ID Numbers: LOPDIR4002
Study First Received: December 9, 2008
Last Updated: July 6, 2012
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection
India: Central Drugs Standard Control Organization

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Antidiarrheals

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Loperamide
Antidiarrheals
Simethicone
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Emollients
Dermatologic Agents

ClinicalTrials.gov processed this record on June 18, 2013