Rifaximin for Prevention of Travellers' Diarrhea

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00742469
• Collaborator: (none)
• Enrollment: 210
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 9.6

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

Condition or Disease	Intervention/Treatment	Phase
Diarrhea	Drug: Rifaximin; Drug: Placebo	Phase 3

Detailed Description

To determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

Study Design

• Study Type: Interventional
• Actual Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Prevention
• Official Title: A Randomized,Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Rifaximin for the Prevention of Travellers' Diarrhea
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: Sep 1, 2005
• Actual Study Completion Date: Apr 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Rifaximin	Drug: Rifaximin
Placebo Comparator: 2 Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment [14 days]

   The efficacy of 14 days of rifaximin 600 mg once daily (QD) compared with placebo when taken by healthy subjects to prevent travelers' diarrhea (TD) resulting from all causes.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. travelling to Mexico within 72 hours of enrollment

2. read and understand English

3. in good health

Exclusion Criteria:

1. acute diarrhea within previous 7 days

2. taken FQs (any drug in this class), macrolide, azalide, or trimethoprim-sulfamethoxazole within 7 days or enrollment or anytime during study.

3. taken antidiarrheal medication within 24 hours of enrollment or anytime during study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of San Diego	Guadalajara	Jalisco	Mexico	45090

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT00742469
• Other Study ID Numbers: RFID3003
• First Posted: Aug 27, 2008
• Last Update Posted: Dec 18, 2019
• Last Verified: Dec 1, 2019

• Keywords provided by Bausch Health Americas, Inc.: TD; traveller's diarrhea; campylobacter; shigella; salmonella; E. coli; diarrhea
• Additional relevant MeSH terms: Diarrhea; Rifaximin

Study Results

Participant Flow

Arm/Group Title	Treatment Arm 1	Placebo Arm
Arm/Group Description	Rifaximin 600 MG QD	Matching Placebo 600MG QD
Period Title: Overall Study
STARTED	106	104
COMPLETED	88	69
NOT COMPLETED	18	35

Baseline Characteristics

Arm/Group Title	Treatment Arm 1	Placebo Arm	Total
Arm/Group Description	Rifaximin 600 MG QD	Matching Placebo 600MG QD	Total of all reporting groups
Overall Participants	106	104	210
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.5 (9.15)	22.9 (7.28)	23.2 (8.26)
Sex: Female, Male (Count of Participants)
Female	66 62.3%	70 67.3%	136 64.8%
Male	40 37.7%	34 32.7%	74 35.2%

Outcome Measures

1. Primary Outcome

Title	Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment
Description	The efficacy of 14 days of rifaximin 600 mg once daily (QD) compared with placebo when taken by healthy subjects to prevent travelers' diarrhea (TD) resulting from all causes.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

The Intent to Treat (ITT) population received at least 1 dose of the study drug. For the ITT population, 99 participants were in the rifaximin group and 102 were in the placebo group. The EE consisted of105 of 106 subjects and the placebo group, 100 of 104 subjects were EE. All subject included in Safety analysis

Arm/Group Title	Treatment Arm	Placebo Arm
Arm/Group Description	Rifaximin Rifaximin	Placebo Placebo
Measure Participants	99	102
Count of Participants [Participants]	15 14.2%	48 46.2%

Adverse Events

Time Frame	14 days
Arm/Group Title	Treatment Arm		Placebo
Arm/Group Description	Rifaximin 600 MG QD		Matching Placebo 600MG QD
All Cause Mortality
	Treatment Arm		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Treatment Arm		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/106 (0%)		0/104 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Arm		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	81/106 (76.4%)		93/104 (89.4%)
Gastrointestinal disorders
Diarrhea	62/106 (58.5%)		83/104 (79.8%)
Abdominal Pain	46/106 (43.4%)		63/104 (60.6%)
Defecation Urgency	33/106 (31.1%)		43/104 (41.3%)
Flatulence	27/106 (25.5%)		29/104 (27.9%)
Vomiting	9/106 (8.5%)		8/104 (7.7%)
Rectal tenesmus	7/106 (6.6%)		13/104 (12.5%)
Hematochezia	5/106 (4.7%)		6/104 (5.8%)
General disorders
Pyrexia	6/106 (5.7%)		6/104 (5.8%)
Nervous system disorders
headache	9/106 (8.5%)		10/104 (9.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.