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

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ClinicalTrials.gov Identifier: NCT01142089
Recruitment Status : Completed
First Posted : June 11, 2010
Results First Posted : April 10, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Traveler's Diarrhea Drug: Placebo Drug: Rifamycin SV MMX Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Rifamycin SV MMX for the Treatment of Traveler's Diarrhea
Study Start Date : May 27, 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo (two matching tablets) orally twice daily for 3 days (72 hours)
Drug: Placebo
Placebo (two matching tablets) orally twice daily for 3 days (72 hours).

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




Primary Outcome Measures :
  1. Time to Last Unformed Stool (TLUS) [ Time Frame: 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 :
  1. Clinical Cure [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients were enrolled in the study only if they met all of the following criteria:

  1. Male and female patients 18 years of age or older
  2. 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
  3. Recent travel (i.e., must be within 30 days of randomization) from an industrialized country
  4. 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
  5. 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)
  6. Capable of and willing to give informed consent

Exclusion Criteria

Patients were excluded from the study if they met any of the following criteria:

  1. 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
  2. Known or suspected infection with non-bacterial pathogen before randomization
  3. Presence of diarrhea for > 72 hours duration
  4. Presence of grossly bloody stool
  5. Presence of moderate to severe dehydration (i.e., presence of orthostatic hypotension and/or dehydration requiring treatment with intravenous fluids)
  6. 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.
  7. Receiving more than two doses of an antidiarrheal medication (e.g., antimotility, absorbent, adsorbent, antisecretory, or probiotics) within 24 hours before randomization
  8. 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
  9. Females pregnant or breast feeding or not using adequate birth control
  10. Known intolerance/hypersensitivity/resistance to rifamycin or rifamycin-related antibiotics or to any excipient included in the study medications
  11. Patients unable or unwilling to comply with study protocol (e.g., alcoholism, mental illness, travel schedule)
  12. Participation in a clinical study with another investigational drug in the 30 days prior to randomization or while participating in this study
  13. Previous participation in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142089


Locations
Guatemala
Santarus Investigational Site 03
Antigua, Guatemala, 03001
Santarus Investigational Site 14
Antigua, Guatemala
Santarus Investigational Site 04
Quetzaltenango, Guatemala, 09001
Mexico
Santarus Investigational Site 05
Guadalajara, Jalisco, Mexico, 42670
Santarus Investigational Site 06
Cuernavaca, Morelos, Mexico, 62240
Santarus Investigational Site 12
Cabo San Lucas, Mexico, 23440
Santarus Investigational Site 10
Cancun, Mexico, 77500
Santarus Investigational Site 07
Oaxaca, Mexico, 6800
Santarus Investigational Site 08
Puebla, Mexico, 72197
Santarus Investigational Site 09
Puerto Escondido, Mexico, 71980
Santarus Investigational Site 11
Puerto Vallarta, Mexico, 48330
Santarus Investigational Site 13
Tulum, Mexico, 77760
Sponsors and Collaborators
Cosmo Technologies Ltd
Valeant Pharmaceuticals International, Inc.
Investigators
Principal Investigator: Herbert DuPont, MD Valeant Pharmaceuticals International, Inc.

Responsible Party: Cosmo Technologies Ltd
ClinicalTrials.gov Identifier: NCT01142089     History of Changes
Other Study ID Numbers: C2009-0201
First Posted: June 11, 2010    Key Record Dates
Results First Posted: April 10, 2018
Last Update Posted: June 8, 2018
Last Verified: April 2018

Keywords provided by Cosmo Technologies Ltd:
traveler's
diarrhea
Rifamycin SV MMX
Rifamycin
MMX
Traveler's Diarrhea

Additional relevant MeSH terms:
Diarrhea
Dysentery
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Rifamycins
Rifamycin SV
Anti-Bacterial Agents
Anti-Infective Agents
Antirheumatic Agents