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

NCT02920242 | Terminated Phase 3 Results

• 1 other identifier: 1526 RIF_2
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Travelers' Diarrhea

Keywords

Travelers; diarrhea; rifaximin; equivalence

Outcome Measures

Primary Outcomes (1)

• 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.

  study day 5 +/- 1 day

Secondary Outcomes (6)

• Time to Last Unformed Stool

  within 5 study days

• Proportion of Patients With Clinical Failure

  within 5 study days

• Proportion of Patients With Improvement of Diarrheal Syndrome

  within 5 study days

• Number of Unformed Stools

  within 5 study days

• The Presence or Absence and Severity of Signs and Symptoms of Enteric Infection

  within 5 study days

Study Arms (3)

Rifaximin

EXPERIMENTAL

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

Drug: Rifaximin (Sandoz GmbH) tablet

Xifaxan

ACTIVE COMPARATOR

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

Drug: Rifaximin (Xifaxan)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Rifaximin (Sandoz GmbH) tablet DRUG

200 mg tablet administered orally.

Rifaximin

Rifaximin (Xifaxan) DRUG

200 mg tablet administered orally

Also known as: Xifaxan®

Xifaxan

Placebo DRUG

Matching Placebo tablet administered orally

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sandoz: lead

Study Sites (1)

Sandoz Investigative Site

Mexico City, Mexico

Location

MeSH Terms

Conditions

Diarrhea

Interventions

Rifaximin; Tablets

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartisemail@novartis.com

862-778-1873

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: September 30, 2016
• Study Start: December 15, 2016
• Primary Completion: May 23, 2017
• Study Completion: May 23, 2017
• Last Updated: March 25, 2019
• Results First Posted: March 25, 2019

Record last verified: 2018-12

Locations

ME (1)