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A Comparison of Three Medications to Treat Diarrhea in Adults.

Primary Purpose

Diarrhea

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Loperamide/simeticone 2 mg/125 mg caplets

Loperamide/simeticone 2 mg/125 mg chewable tablets

Probiotic Saccharomyces boulardii 250 mg capsules

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring Antidiarrheals

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Manipal Goa Hospital
Vrundavan Hospital & Research Centre
North West Medical
Dr. Maxwell´s Clinic
Hospital Amerimed Puerto Vallarta
Servicios Medicos de la Bahia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Loperamide/simeticone Caplets

Loperamide/simeticone Chewable Tablets

Probiotic Capsules

Arm Description

Drug (including placebo)

Outcomes

Primary Outcome Measures

Number of unformed stools

Secondary Outcome Measures

Number of unformed stools

Time to last unformed stool

Time to complete relief of abdominal discomfort

Time to complete relief of diarrhea

Proportion of subjects with complete relief of diarrhea

Gas-related abdominal discomfort ratings - change from baseline at subsequent time points

Proportions of subjects with complete well-being

Subject's evaluation of treatment effectiveness for overall illness relief, diarrhea relief and abdominal discomfort relief

Number of loperamide/simeticone 2 mg/125 mg caplets or chewable tablets or probiotic (Saccharomyces boulardii) 250 mg capsules used during the study

Frequency of complete well-being following diarrhea illness

Stool frequency

Frequency of diarrhea relapse

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.

Full Information

NCT ID

NCT00807326

First Posted

December 9, 2008

Last Updated

July 6, 2012

Sponsor

McNeil AB

1. Study Identification

Unique Protocol Identification Number

NCT00807326

Brief Title

A Comparison of Three Medications to Treat Diarrhea in Adults.

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 Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McNeil AB

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A comparison of three medications to treat diarrhea in adults.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diarrhea

Keywords

Antidiarrheals

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

415 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Loperamide/simeticone Caplets

Arm Type

Experimental

Arm Description

Drug (including placebo)

Arm Title

Loperamide/simeticone Chewable Tablets

Arm Type

Active Comparator

Arm Description

Drug (including placebo)

Arm Title

Probiotic Capsules

Arm Type

Active Comparator

Arm Description

Drug (including placebo)

Intervention Type

Drug

Intervention Name(s)

Loperamide/simeticone 2 mg/125 mg caplets

Other Intervention Name(s)

Imodium® Plus Caplet

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Loperamide/simeticone 2 mg/125 mg chewable tablets

Other Intervention Name(s)

Imodium® Plus Chewable tablet

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Probiotic Saccharomyces boulardii 250 mg capsules

Other Intervention Name(s)

Perenterol® Forte 250mg capsules

Intervention Description

Oral, 1 capsule twice a day, maximum 2 capsules in a 24 hour period for a maximum of 5 days (per product label)

Primary Outcome Measure Information:

Title

Number of unformed stools

Time Frame

0-24 hours

Secondary Outcome Measure Information:

Title

Number of unformed stools

Time Frame

0-12, 12-24, 24-36, 36-48 hours

Title

Time to last unformed stool

Time Frame

Throughout duration of the study

Title

Time to complete relief of abdominal discomfort

Time Frame

Throughout duration of the study

Title

Time to complete relief of diarrhea

Time Frame

Throughout duration of the study

Title

Proportion of subjects with complete relief of diarrhea

Time Frame

4, 8, 12, 24 and 48 hours

Title

Gas-related abdominal discomfort ratings - change from baseline at subsequent time points

Time Frame

Throughout duration of the study

Title

Proportions of subjects with complete well-being

Time Frame

at 12, 24 and 48 hours.

Title

Subject's evaluation of treatment effectiveness for overall illness relief, diarrhea relief and abdominal discomfort relief

Time Frame

Throughout duration of the study

Title

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

Title

Frequency of complete well-being following diarrhea illness

Time Frame

at 7 days follow up

Title

Stool frequency

Time Frame

at 7 days follow up

Title

Frequency of diarrhea relapse

Time Frame

at 7 days follow up

Title

Time Frame

throughout duration of the study (+ 30 days for spontaneously-reported SAEs)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elisabeth Kruse, PhD

Organizational Affiliation

McNeil AB

Official's Role

Study Director

Facility Information:

Facility Name

Manipal Goa Hospital

City

Goa

ZIP/Postal Code

403004

Country

India

Facility Name

Vrundavan Hospital & Research Centre

City

Goa

ZIP/Postal Code

403527

Country

India

Facility Name

North West Medical

City

San José del Cabo

State/Province

Baja California Sur

ZIP/Postal Code

22447

Country

Mexico

Facility Name

Dr. Maxwell´s Clinic

City

San Miguel de Allende

State/Province

Guanuajuato

ZIP/Postal Code

37700

Country

Mexico

Facility Name

Hospital Amerimed Puerto Vallarta

City

Puerto Vallarta

State/Province

Jalisco

ZIP/Postal Code

48300

Country

Mexico

Facility Name

Servicios Medicos de la Bahia

City

Puerto Vallarta

State/Province

Jalisco

ZIP/Postal Code

48300

Country

Mexico

12. IPD Sharing Statement

Citations:

PubMed Identifier

26541878

Citation

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.

Results Reference

derived

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A Comparison of Three Medications to Treat Diarrhea in Adults.

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