Study to Evaluate Safety and Efficacy of Rifamycin SV Multi-Matrix System (MMX) for the Treatment of Traveler's Diarrhea (TD)

NCT01142089 | Completed Phase 3 Results

• 1 other identifier: C2009-0201
• Study Type: interventional
• Target: 264
• Locations: 2 countries
• Sites: 12

Brief Summary

The purpose of this study is to determine whether Rifamycin SV MMX is a safe and effective treatment for Traveler's Diarrhea.

Conditions

Traveler's Diarrhea

Keywords

traveler's; diarrhea; Rifamycin SV MMX; Rifamycin; MMX; Traveler's Diarrhea

Outcome Measures

Primary Outcomes (1)

• Time to Last Unformed Stool (TLUS)

  The primary endpoint is TLUS defined as the interval in hours between the first dose of study drug and the last unformed stool passed just before the start of Clinical Cure. An unformed stool is defined as either a soft or watery stool. TLUS will be calculated for each patient in the following manner: Step 1: Identify when the patient achieves Clinical Cure. Step 2: Moving backwards from this time, identify the time of the last unformed stool. Step 3: The TLUS equals the time from the first dose of study drug to the time of the last unformed stool identified in Step 2.

  24 hours

Secondary Outcomes (1)

• Clinical Cure

  24 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (two matching tablets) orally twice daily for 3 days (72 hours)

Drug: Placebo

Rifamycin SV MMX

EXPERIMENTAL

Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).

Drug: Rifamycin SV MMX

Interventions

Placebo DRUG

Placebo (two matching tablets) orally twice daily for 3 days (72 hours).

Placebo

Rifamycin SV MMX DRUG

Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).

Rifamycin SV MMX

Eligibility Criteria

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

You may qualify if:

• Patients were enrolled in the study only if they met all of the following criteria:
• Male and female patients 18 years of age or older
• Female and male patients of childbearing potential must have agreed to use an effective method of birth control (this method must have been approved by the investigator and may have included total abstinence from sexual intercourse) during the treatment and follow-up study periods; female patients of childbearing potential must have had a negative pregnancy test in the 72 hours before randomization; female patients who abstained totally from sexual intercourse were not required to take the pregnancy test
• Recent travel (i.e., must be within 30 days of randomization) from an industrialized country
• Experiencing signs or symptoms indicative of acute bacterial diarrhea (TD), defined as at least three unformed, watery or soft, stools within the 24 hours preceding randomization and the duration of illness 72 hours before randomization, and able to provide an unformed stool sample during Screening (the latter can be the third unformed stool passed by the patient within the 24 hours preceding randomization); the bacterial cause of diarrhea was confirmed by microbiology analysis of the stool sample
• Experiencing one or more signs or symptoms of enteric infection (moderate to severe gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, or defecation urgency)
• Capable of and willing to give informed consent

You may not qualify if:

• Patients were excluded from the study if they met any of the following criteria:
• Fever (\> 100.4F or 38C) or presence of signs and symptoms of systemic infection Note: antipyretic medication should not have been administered in the 6 hours before this assessment
• Known or suspected infection with non-bacterial pathogen before randomization
• Presence of diarrhea for \> 72 hours duration
• Presence of grossly bloody stool
• Presence of moderate to severe dehydration (i.e., presence of orthostatic hypotension and/or dehydration requiring treatment with intravenous fluids)
• History of ulcerative colitis, diarrhea-predominant irritable bowel syndrome, Crohn's disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or any other gastrointestinal disease associated with diarrhea. Note: lactose intolerance treated with lactase supplements or a lactose-free diet were not excluded if these regimens were maintained during the study.
• Receiving more than two doses of an antidiarrheal medication (e.g., antimotility, absorbent, adsorbent, antisecretory, or probiotics) within 24 hours before randomization
• Receiving one or more of the following antibiotics, which are active against gram negative bacteria TMP-SMX, fluorquinolone, azithromycin or rifaximin within 7 days before randomization
• Females pregnant or breast feeding or not using adequate birth control
• Known intolerance/hypersensitivity/resistance to rifamycin or rifamycin-related antibiotics or to any excipient included in the study medications
• Patients unable or unwilling to comply with study protocol (e.g., alcoholism, mental illness, travel schedule)
• Participation in a clinical study with another investigational drug in the 30 days prior to randomization or while participating in this study
• Previous participation in this study

Sponsors & Collaborators

• Cosmo Technologies Ltd: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (12)

Santarus Investigational Site 03

Antigua Guatemala, 03001, Guatemala

Location

Santarus Investigational Site 14

Antigua Guatemala, Guatemala

Location

Santarus Investigational Site 04

Quetzaltenango, 09001, Guatemala

Location

Santarus Investigational Site 05

Guadalajara, Jalisco, 42670, Mexico

Location

Santarus Investigational Site 06

Cuernavaca, Morelos, 62240, Mexico

Location

Santarus Investigational Site 12

Cabo San Lucas, 23440, Mexico

Location

Santarus Investigational Site 10

Cancún, 77500, Mexico

Location

Santarus Investigational Site 07

Oaxaca City, 6800, Mexico

Location

Santarus Investigational Site 08

Puebla City, 72197, Mexico

Location

Santarus Investigational Site 09

Puerto Escondido, 71980, Mexico

Location

Santarus Investigational Site 11

Puerto Vallarta, 48330, Mexico

Location

Santarus Investigational Site 13

Tulum, 77760, Mexico

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Richard Jones
• Organization: Cosmo Technologies Ltd.

RJones@cosmopharma.com

+35318170370

Study Officials

• Herbert DuPont, MD

  Bausch Health Americas, Inc.

  PRINCIPAL INVESTIGATOR

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: June 9, 2010
• First Posted: June 11, 2010
• Study Start: May 27, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 8, 2018
• Results First Posted: April 10, 2018

Record last verified: 2018-04

Locations

GU (3); ME (9)