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

Phase 3

Completed

• Conditions: Traveler's Diarrhea
• Interventions: Drug: Rifamycin SV MMX; Drug: Placebo

• Registration Number: NCT01142089
• Lead Sponsor: Cosmo Technologies Ltd

Brief Summary

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

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study conducted in patients traveling to developing regions with a known high incidence of TD. Eligibility will be based on a symptom complex that is highly indicative of enteric acute bacterial infection without indication of systemic infection.

Approximately 262 patients will be enrolled in the study and randomized at a 3:1 ratio to receive Rifamycin SV MMX® 400 mg or placebo orally twice daily for 3 days (72 hours). Treatment will be initiated on the day of Screening (Visit 1, Day 1), within 72 hours of onset of diarrhea. Daily doses of study drug will be taken at breakfast time and dinner time with a glass of liquid.

Safety and efficacy will be assessed.

Blood samples for routine safety tests (chemistry and hematology) will be collected at Visit 1 and at Visit 3 and sent to a local laboratory for analysis and reporting to the Investigator for safety monitoring. Urine samples for routine urinalysis (dipstick only) will be collected at Visits 1 and 3, and the results will be used by the Investigator for safety monitoring.

If a patient's diarrhea and/or signs or symptoms of enteric infection worsen in a 24 hour interval of time during the treatment period or if the enteric illness fails to improve after 24 hours or more of therapy, the patient may receive Rescue Therapy. Rescue Therapy will be prescribed by the Investigator using local standard empiric therapy and/or guided by pathogen identification.

Study Timeline

• Study Start: 2010-05-27
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Disposition First Submitted: 2013-04-05
• Disposition First Submitted QC: 2013-04-12
• Disposition First Posted: 2013-04-19
• Results First Submitted: 2018-02-09
• Results First Submitted QC: 2018-03-13
• Status Verified: 2018-04
• Results First Posted: 2018-04-10
• Last Update Submitted: 2018-05-10
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Time to Last Unformed Stool (TLUS)	24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Cure	24 hours	Clinical Cure is defined as either of the following: * Passage of two or fewer soft stools and no watery stools, no fever (\>100.4 ºF or 38 ºC), and no signs or symptoms of enteric infection (other than mild excess gas/flatulence) during a 24 hour interval in the 120-hr data collection period after the first dose of study drug; * Passage of no stools or only formed stools and no fever during a 48-hour interval in the 120-hr data collection period after the first dose of study drug, with or without other signs or symptoms of enteric infection

Trial Locations

Locations (12)

Santarus Investigational Site 06; 🇲🇽 Cuernavaca, Morelos, Mexico

Santarus Investigational Site 10; 🇲🇽 Cancun, Mexico

Santarus Investigational Site 07; 🇲🇽 Oaxaca, Mexico

Santarus Investigational Site 09; 🇲🇽 Puerto Escondido, Mexico

Santarus Investigational Site 11; 🇲🇽 Puerto Vallarta, Mexico

Santarus Investigational Site 13; 🇲🇽 Tulum, Mexico

Santarus Investigational Site 14; 🇬🇹 Antigua, Guatemala

Santarus Investigational Site 04; 🇬🇹 Quetzaltenango, Guatemala

Santarus Investigational Site 05; 🇲🇽 Guadalajara, Jalisco, Mexico

Santarus Investigational Site 03; 🇬🇹 Antigua, Guatemala

Santarus Investigational Site 12; 🇲🇽 Cabo San Lucas, Mexico

Santarus Investigational Site 08; 🇲🇽 Puebla, Mexico