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Trial Outcomes & Findings for A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea. (NCT NCT02920242)

NCT ID: NCT02920242

Last Updated: 2019-03-25

Results Overview

Clinical cure was defined as either no stools or only formed stools within a 48 hour period and no fever, with or without other enteric symptoms, OR no watery stools or no more than two soft stools passed within a 24 hour period with no fever and no other enteric symptoms except for mild excess gas/flatulence.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

28 participants

Primary outcome timeframe

study day 5 +/- 1 day

Results posted on

2019-03-25

Participant Flow

Participant milestones

Participant milestones
Measure
Rifaximin
Patients received Rifaximin 200 mg tablet 3 times per day for 3 days.
Xifaxan
Patients received Xifaxan 200 mg tablet 3 times per day for 3 days.
Placebo
Patients received placebo tablet 3 times per day for 3 days.
Overall Study
STARTED
13
11
4
Overall Study
Safety Set
12
11
4
Overall Study
COMPLETED
11
11
3
Overall Study
NOT COMPLETED
2
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Rifaximin
Patients received Rifaximin 200 mg tablet 3 times per day for 3 days.
Xifaxan
Patients received Xifaxan 200 mg tablet 3 times per day for 3 days.
Placebo
Patients received placebo tablet 3 times per day for 3 days.
Overall Study
Withdrawal by Subject
1
0
1
Overall Study
Did not meet inc./exc. criteria
1
0
0

Baseline Characteristics

A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Rifaximin
n=12 Participants
Patients received Rifaximin 200 mg tablet 3 times per day for 3 days.
Xifaxan
n=11 Participants
Patients received Xifaxan 200 mg tablet 3 times per day for 3 days.
Placebo
n=4 Participants
Patients received placebo tablet 3 times per day for 3 days.
Total
n=27 Participants
Total of all reporting groups
Age, Continuous
36.3 Years
STANDARD_DEVIATION 18.27 • n=5 Participants
38.2 Years
STANDARD_DEVIATION 18.69 • n=7 Participants
35.8 Years
STANDARD_DEVIATION 21.93 • n=5 Participants
37.0 Years
STANDARD_DEVIATION 18.22 • n=4 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
7 Participants
n=7 Participants
1 Participants
n=5 Participants
13 Participants
n=4 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
4 Participants
n=7 Participants
3 Participants
n=5 Participants
14 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
White
11 Participants
n=5 Participants
11 Participants
n=7 Participants
4 Participants
n=5 Participants
26 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants

PRIMARY outcome

Timeframe: study day 5 +/- 1 day

Population: The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.

Clinical cure was defined as either no stools or only formed stools within a 48 hour period and no fever, with or without other enteric symptoms, OR no watery stools or no more than two soft stools passed within a 24 hour period with no fever and no other enteric symptoms except for mild excess gas/flatulence.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 5 study days

Population: The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 5 study days

Population: The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 5 study days

Population: The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 5 study days

Population: The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 5 study days

Population: The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: study day 5

Population: The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.

Outcome measures

Outcome data not reported

Adverse Events

Rifaximin

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Xifaxan

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Rifaximin
n=12 participants at risk
Patients received Rifaximin 200 mg tablet 3 times per day for 3 days.
Xifaxan
n=11 participants at risk
Patients received Xifaxan 200 mg tablet 3 times per day for 3 days.
Placebo
n=4 participants at risk
Patients received placebo tablet 3 times per day for 3 days.
Eye disorders
Lacrimation increased
0.00%
0/12 • up to day 5 +/- 1 day
9.1%
1/11 • up to day 5 +/- 1 day
0.00%
0/4 • up to day 5 +/- 1 day
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/12 • up to day 5 +/- 1 day
9.1%
1/11 • up to day 5 +/- 1 day
0.00%
0/4 • up to day 5 +/- 1 day
Gastrointestinal disorders
Constipation
8.3%
1/12 • up to day 5 +/- 1 day
0.00%
0/11 • up to day 5 +/- 1 day
0.00%
0/4 • up to day 5 +/- 1 day
Injury, poisoning and procedural complications
Medication error
0.00%
0/12 • up to day 5 +/- 1 day
9.1%
1/11 • up to day 5 +/- 1 day
0.00%
0/4 • up to day 5 +/- 1 day
Nervous system disorders
Dizziness
0.00%
0/12 • up to day 5 +/- 1 day
18.2%
2/11 • up to day 5 +/- 1 day
0.00%
0/4 • up to day 5 +/- 1 day
Nervous system disorders
Headache
8.3%
1/12 • up to day 5 +/- 1 day
27.3%
3/11 • up to day 5 +/- 1 day
0.00%
0/4 • up to day 5 +/- 1 day

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-1873

Results disclosure agreements

  • Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
  • Publication restrictions are in place

Restriction type: OTHER