Trial Outcomes & Findings for Rifaximin for Prevention of Travellers' Diarrhea (NCT NCT00742469)

Last Updated: 2019-12-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

210 participants

Primary outcome timeframe

14 days

Results posted on

2019-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm 1 Rifaximin 600 MG QD	Placebo Arm Matching Placebo 600MG QD
Overall Study STARTED	106	104
Overall Study COMPLETED	88	69
Overall Study NOT COMPLETED	18	35

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rifaximin for Prevention of Travellers' Diarrhea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm 1 n=106 Participants Rifaximin 600 MG QD	Placebo Arm n=104 Participants Matching Placebo 600MG QD	Total n=210 Participants Total of all reporting groups
Age, Continuous	23.5 years STANDARD_DEVIATION 9.15 • n=93 Participants	22.9 years STANDARD_DEVIATION 7.28 • n=4 Participants	23.2 years STANDARD_DEVIATION 8.26 • n=27 Participants
Sex: Female, Male Female	66 Participants n=93 Participants	70 Participants n=4 Participants	136 Participants n=27 Participants
Sex: Female, Male Male	40 Participants n=93 Participants	34 Participants n=4 Participants	74 Participants n=27 Participants

PRIMARY outcome

Timeframe: 14 days

Population: 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

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.

Outcome measures

Outcome measures
Measure	Treatment Arm n=99 Participants Rifaximin Rifaximin	Placebo Arm n=102 Participants Placebo Placebo
Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment	15 Participants	48 Participants

Adverse Events

Treatment Arm

Serious events: 0 serious events

Other events: 81 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 93 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Arm n=106 participants at risk Rifaximin 600 MG QD	Placebo n=104 participants at risk Matching Placebo 600MG QD
Gastrointestinal disorders Diarrhea	58.5% 62/106 • 14 days	79.8% 83/104 • 14 days
Gastrointestinal disorders Abdominal Pain	43.4% 46/106 • 14 days	60.6% 63/104 • 14 days
Gastrointestinal disorders Defecation Urgency	31.1% 33/106 • 14 days	41.3% 43/104 • 14 days
Gastrointestinal disorders Flatulence	25.5% 27/106 • 14 days	27.9% 29/104 • 14 days
Gastrointestinal disorders Vomiting	8.5% 9/106 • 14 days	7.7% 8/104 • 14 days
Gastrointestinal disorders Rectal tenesmus	6.6% 7/106 • 14 days	12.5% 13/104 • 14 days
Gastrointestinal disorders Hematochezia	4.7% 5/106 • 14 days	5.8% 6/104 • 14 days
Nervous system disorders headache	8.5% 9/106 • 14 days	9.6% 10/104 • 14 days
General disorders Pyrexia	5.7% 6/106 • 14 days	5.8% 6/104 • 14 days

Additional Information

Valeant Pharmaceuticals

Phone: (866) 246-8245

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place