A Comparison of Three Medications to Treat Diarrhea in Adults.

Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807326
• Other study ID #: LOPDIR4002
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2008
• Last updated: July 6, 2012
• Start date: November 2008
• Est. completion date: November 2009

Study information

• Verified date: July 2012
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks ProtectionIndia: Central Drugs Standard Control Organization
• Study type: Interventional

Clinical Trial Summary

A comparison of three medications to treat diarrhea in adults.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: November 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea

Intervention

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)
• 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)
• 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)

Locations

Country	Name	City	State
India	Manipal Goa Hospital	Goa
India	Vrundavan Hospital & Research Centre	Goa
Mexico	Hospital Amerimed Puerto Vallarta	Puerto Vallarta	Jalisco
Mexico	Servicios Medicos de la Bahia	Puerto Vallarta	Jalisco
Mexico	North West Medical	San José del Cabo	Baja California Sur
Mexico	Dr. Maxwell´s Clinic	San Miguel de Allende	Guanuajuato

Sponsors (1)

Lead Sponsor	Collaborator
McNeil AB

Countries where clinical trial is conducted

India,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of unformed stools		0-24 hours	No
Secondary	Number of unformed stools		0-12, 12-24, 24-36, 36-48 hours	No
Secondary	Time to last unformed stool		Throughout duration of the study	No
Secondary	Time to complete relief of abdominal discomfort		Throughout duration of the study	No
Secondary	Time to complete relief of diarrhea		Throughout duration of the study	No
Secondary	Proportion of subjects with complete relief of diarrhea		4, 8, 12, 24 and 48 hours	No
Secondary	Gas-related abdominal discomfort ratings - change from baseline at subsequent time points		Throughout duration of the study	No
Secondary	Proportions of subjects with complete well-being		at 12, 24 and 48 hours.	No
Secondary	Subject's evaluation of treatment effectiveness for overall illness relief, diarrhea relief and abdominal discomfort relief		Throughout duration of the study	No
Secondary	Number of loperamide/simeticone 2 mg/125 mg caplets or chewable tablets or probiotic (Saccharomyces boulardii) 250 mg capsules used during the study		Throughout duration of the study	No
Secondary	Frequency of complete well-being following diarrhea illness		at 7 days follow up	No
Secondary	Stool frequency		at 7 days follow up	No
Secondary	Frequency of diarrhea relapse		at 7 days follow up	No
Secondary	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.		throughout duration of the study (+ 30 days for spontaneously-reported SAEs)	No