Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea

NCT02498418 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ACTA/RIFX/2015
• Study Type: interventional
• Target: 739
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to demonstrate rifaximin 200 milligrams (mg) tablets (test) and Xifaxan® 200 mg tablets (reference) are clinically bioequivalent with respect to the clinical cure rates when administered 3 times a day (TID) for 3 days in participants with travelers' diarrhea.

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Achieved Clinical Cure at Test of Cure (TOC) Visit (Within 24 to 72 Hours From the Time of Last Dose): Per-Protocol (PP) Population

  Clinical cure was defined as either of the following: 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 2 soft stools passed within a 24-hour period with no fever and no other enteric symptoms except for mild excess gas/flatulence. Bioequivalence evaluation between test (generic rifaximin 200 mg tablets) and reference groups (xifaxan 200 mg tablets) was conducted in this endpoint, hence placebo group was not included. Participants who were discontinued early from the study due to lack of treatment effect after completing 9 doses within 72 hours from the time of first dose were included in the PP population using Last Observation Carried Forward (LOCF) method. Additionally, participants whose condition worsened and who required alternate or supplemental therapy for the treatment of travelers' diarrhea were discontinued and included in the PP population analysis using LOCF.

  TOC visit (Day 5, 6 or 7)

• Number of Participants Who Achieved Clinical Cure at TOC Visit (Within 24 to 72 Hours From the Time of Last Dose): Modified Intent-to-Treat (mITT) Population

  Clinical cure was defined as either of the following: 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 2 soft stools passed within a 24-hour period with no fever and no other enteric symptoms except for mild excess gas/flatulence. Participants discontinued early for reasons other than "lack of treatment effect after completing 9 doses within 72 hours from the time of first dose" and for "participants whose condition worsened and who required alternate or supplemental therapy for the treatment of travelers' diarrhea" were included in the mITT population analysis using LOCF.

  TOC visit (Day 5, 6 ,or 7)

Secondary Outcomes (2)

• Time to Last Unformed Stool (TLUS)

  Day 1 to Day 5

• Percentage of Participants Who Achieved Microbiological Cure at TOC Visit (Within 24 to 72 Hours From the Time of Last Dose)

  TOC visit (Day 5, 6, or 7)

Study Arms (3)

Generic Rifaximin 200 mg Tablets

EXPERIMENTAL

Participants will receive a generic rifaximin 200 mg tablet 3 times daily orally for 3 days.

Drug: Rifaximin

Xifaxan 200 mg Tablets

ACTIVE COMPARATOR

Participants will receive a xifaxan 200 mg tablet 3 times daily orally for 3 days.

Drug: Xifaxan®

Placebo

PLACEBO COMPARATOR

Participants will receive a rifaximin placebo tablet 3 times daily orally for 3 days.

Drug: Placebo Tablet

Interventions

Rifaximin DRUG

Tablets, generic formulation of the brand product.

Generic Rifaximin 200 mg Tablets

Xifaxan® DRUG

Tablets, brand product.

Xifaxan 200 mg Tablets

Placebo Tablet DRUG

Placebo tablets in the same image of the generic rifaximin. Has no active ingredient.

Placebo

Eligibility Criteria

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

You may qualify if:

• Adult male or nonpregnant female aged ≥18 years non-indigenous travelers (for example; visiting students/faculty or international tourists) affected by naturally acquired acute diarrhea. Diarrhea is defined as the passage of at least 3 unformed stools in a 24-hour period. Stools are classified as formed (retains shape), soft (assumes shape of container), or watery (can be poured). When using this classification, both soft and watery stools are unformed and abnormal.
• At least 3 unformed stools recorded within the 24 hours immediately preceding randomization.
• At least 1 of the following signs and symptoms of enteric infection:
• abdominal pain or cramps
• nausea
• vomiting
• fecal urgency
• excessive gas/flatulence
• tenesmus
• Women of child-bearing potential have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study.

You may not qualify if:

• Pregnant, breast feeding, or planning a pregnancy.
• Immediately prior to randomization, acute diarrhea for \>72 hours.
• Presence of:
• fever (≥100 degrees fahrenheit \[°F\] or ≥37.8 degrees celsius \[°C\]), or
• hematochezia (blood in stool), or
• clinical findings suggesting moderate or severe dehydration.
• Active, uncontrolled, or clinically significant diseases or disorders of the heart, lung, kidney, gastrointestinal (GI) tract (other than infectious diarrhea in travelers), or central nervous system.
• Administration of any of the following:
• any antimicrobial agents with an expected activity against enteric bacterial pathogens within 7 days preceding randomization
• more than 2 doses of a symptomatic antidiarrheal compound such as antimotility agents, absorbent agents, and antisecretory agents within 8 hours preceding randomization
• Use of any drug such as aspirin or ibuprofen (Advil), which can cause GI bleeding. Acetaminophen (Tylenol) or paracetamol is acceptable.

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

Site 1

Coral Gables, Florida, 33134, United States

Location

MeSH Terms

Conditions

Diarrhea

Interventions

Rifaximin

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

Results Point of Contact

• Title: Director, CE Studies
• Organization: Teva Pharmaceuticals Inc. USA

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Study Director

  Actavis Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 15, 2015
• Study Start: January 6, 2016
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: December 5, 2019
• Results First Posted: December 5, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)