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Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.

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ClinicalTrials.gov Identifier: NCT00328380
Recruitment Status : Completed
First Posted : May 19, 2006
Last Update Posted : December 23, 2009
Sponsor:
Information provided by:
Valeant Pharmaceuticals International, Inc.

May 17, 2006
May 19, 2006
December 23, 2009
December 2005
December 2006   (Final data collection date for primary outcome measure)
The primary endpoint in this study is the assessment of safety and tolerability of rifaximin 600 mg QD compared to placebo.
Same as current
Complete list of historical versions of study NCT00328380 on ClinicalTrials.gov Archive Site
A secondary endpoints of this study include assessment of the differences between the 2 treatment groups based upon the proportion of subjects with TD during the 14-day Treatment Period.
Same as current
Not Provided
Not Provided
 
Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety of Rifaximin for the Prevention of Travelers' Diarrhea in Subjects Traveling Outside the United States
The primary objective of this study is to assess the safety and tolerability of rifaximin 600 mg (3 x 200-mg tablets) once daily compared with placebo when taken for 14 days by healthy subjects to prevent travelers' diarrhea (TD) from all causes.
Travelers' diarrhea (TD) is the most common illness in travelers to the developing world, occurring in 60% or more of international travelers to high-risk areas. It can be quite debilitating for the usual 2 to 4 days of the illness and may lead to disruption of travel plans. Findings from recent studies have indicated that the chronic post-travel illness may prove to be of greater clinical and public health significance than the acute illness. Specifically, persistent diarrhea has been reported in 2% to 10% of travelers developing diarrhea. Moreover, bacterial enterocolitis, including that associated with TD, leads to post-infectious irritable bowel syndrome in 4% to 31% of patients.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Diarrhea
Drug: Rifaximin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
660
Same as current
September 2008
December 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject is in good health (as determined by medical history)
  2. Subject is planning on traveling anywhere outside the US (except Canada) for at least 5 and no more than 14 days
  3. Subject is scheduled to depart on their planned trip no later than 14 days and no earlier than 4 days after having blood drawn for clinical laboratory assessments and urine collected for a pregnancy test (females of childbearing potential only)

Exclusion Criteria:

  1. Subject has hypersensitivity or allergy to rifaximin or rifampin
  2. Subject has known or suspected alcohol abuse or illicit drug use within 1 year of enrollment
  3. Subject participated in an investigational drug or device study within the 30 days prior to enrollment
  4. Subject received rifaximin in a previous clinical study
  5. Subject received any systemic or gastrointestinal-specific antibiotic within 7 days of the first dose of study drug
  6. Subject received antidiarrheal medication (eg, loperamide, lactobacillus, BSS, Kaopectate®) within 24 hours of the first dose of study drug
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00328380
RFID3004
Not Provided
Not Provided
Not Provided
Not Provided
Valeant Pharmaceuticals International, Inc.
Not Provided
Not Provided
Valeant Pharmaceuticals International, Inc.
December 2009

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