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

Primary Purpose

Travelers' Diarrhea

Status
Terminated
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Rifaximin (Sandoz GmbH) tablet
Rifaximin (Xifaxan)
Placebo
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Travelers' Diarrhea focused on measuring Travelers, diarrhea, rifaximin, equivalence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient is able to read and understood the language of the Informed Consent Form and Patient Information.
  • International travelers with a duration of stay in host country long enough to attend schedules visits.
  • Affected by naturally acquired acute diarrhea, defined as the passage of at least 3 unformed stools within 24 hours immediately preceding randomization preceding randomization

Exclusion Criteria:

  • Hypersensitivity to rifaximin or any of the rifamycin antimicrobial agents or to any of the excipients of the study drug.
  • Pregnant, breast feeding or planning pregnancy
  • Acute diarrhea for > 72 hours immediately prior to randomization.
  • Presence of fever (≥ 100 °F/37.8°C) or hematochezia (blood in stool, noted visually) or clinical findings suggesting moderate or severe dehydration.

Sites / Locations

  • Sandoz Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Rifaximin

Xifaxan

Placebo

Arm Description

Patients received Rifaximin 200 mg tablet 3 times per day for 3 days.

Patients received Xifaxan 200 mg tablet 3 times per day for 3 days.

Patients received placebo tablet 3 times per day for 3 days.

Outcomes

Primary Outcome Measures

Clinical Cure Rate
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.

Secondary Outcome Measures

Time to Last Unformed Stool
Proportion of Patients With Clinical Failure
Proportion of Patients With Improvement of Diarrheal Syndrome
Number of Unformed Stools
The Presence or Absence and Severity of Signs and Symptoms of Enteric Infection
Microbiological Cure Rate

Full Information

First Posted
September 29, 2016
Last Updated
December 20, 2018
Sponsor
Sandoz
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1. Study Identification

Unique Protocol Identification Number
NCT02920242
Brief Title
A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.
Official Title
A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center, Therapeutic Equivalence Study to Compare Rifaximin 200 mg Tablets (Sandoz GmbH) to Xifaxan® 200 mg Tablets (Salix Pharmaceuticals, Inc.) and Placebo in Patients With Travelers' Diarrhea
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to low enrollment
Study Start Date
December 15, 2016 (Actual)
Primary Completion Date
May 23, 2017 (Actual)
Study Completion Date
May 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compared safety and efficacy of a generic rifaximin tablet to the reference listed drug in the treatment of travelers' diarrhea. Additionally both the generic and reference formulations were tested for superiority against a placebo tablet. It was planned that 450 patients would be enrolled, but only 28 patients were randomized. Of these, 1 patient discontinued due to failure to meet the inclusion/exclusion criteria. The remaining 27 patients received study drug and 25 patients completed the study. The study was terminated due to slow enrolment. The final analysis included only safety analysis in the Safety population, due to the low number of randomized patients. No efficacy analysis was performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Travelers' Diarrhea
Keywords
Travelers, diarrhea, rifaximin, equivalence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rifaximin
Arm Type
Experimental
Arm Description
Patients received Rifaximin 200 mg tablet 3 times per day for 3 days.
Arm Title
Xifaxan
Arm Type
Active Comparator
Arm Description
Patients received Xifaxan 200 mg tablet 3 times per day for 3 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients received placebo tablet 3 times per day for 3 days.
Intervention Type
Drug
Intervention Name(s)
Rifaximin (Sandoz GmbH) tablet
Intervention Description
200 mg tablet administered orally.
Intervention Type
Drug
Intervention Name(s)
Rifaximin (Xifaxan)
Other Intervention Name(s)
Xifaxan®
Intervention Description
200 mg tablet administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo tablet administered orally
Primary Outcome Measure Information:
Title
Clinical Cure Rate
Description
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.
Time Frame
study day 5 +/- 1 day
Secondary Outcome Measure Information:
Title
Time to Last Unformed Stool
Time Frame
within 5 study days
Title
Proportion of Patients With Clinical Failure
Time Frame
within 5 study days
Title
Proportion of Patients With Improvement of Diarrheal Syndrome
Time Frame
within 5 study days
Title
Number of Unformed Stools
Time Frame
within 5 study days
Title
The Presence or Absence and Severity of Signs and Symptoms of Enteric Infection
Time Frame
within 5 study days
Title
Microbiological Cure Rate
Time Frame
study day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is able to read and understood the language of the Informed Consent Form and Patient Information. International travelers with a duration of stay in host country long enough to attend schedules visits. Affected by naturally acquired acute diarrhea, defined as the passage of at least 3 unformed stools within 24 hours immediately preceding randomization preceding randomization Exclusion Criteria: Hypersensitivity to rifaximin or any of the rifamycin antimicrobial agents or to any of the excipients of the study drug. Pregnant, breast feeding or planning pregnancy Acute diarrhea for > 72 hours immediately prior to randomization. Presence of fever (≥ 100 °F/37.8°C) or hematochezia (blood in stool, noted visually) or clinical findings suggesting moderate or severe dehydration.
Facility Information:
Facility Name
Sandoz Investigative Site
City
Mexico City
Country
Mexico

12. IPD Sharing Statement

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

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