Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 90
Updated:5/5/2014
Start Date:October 2010
End Date:September 2013
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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Trial Summary
Trial Overview
Inclusion Criteria

Multi-center, Randomized, Evaluator-blind, Active-controlled,Parallel-group Design to Determine Safety, Tolerability, and Efficacy of Multiple Daily Administration of LFF571 for 10 Days in Patients With Moderate Clostridium Difficile Infections

This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in
patients who have moderate Clostridium difficile infections.


Inclusion Criteria:

- Males and females between 18 and 90 years of age, inclusive.

- Diagnosed with primary episode or first relapse of moderate C. difficile infection.

Received ≤24 hours of therapy effective for C. difficile infection prior to enrollment.

Exclusion Criteria:

- Severe C. difficile infection

- Expected to require more than 10 days of C. difficile infection treatment.

- More than one prior episode of C. difficile infection within the prior 3 months.

- Use of anti-peristaltic drugs (including tincture of opium, metoclopramide,
loperamide),, cholestyramine, or colestipol

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
34
sites
Novartis Investigative Site
Mineola, New York 11501
172
mi
from 02139
Mineola, NY
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Novartis Investigative Site
Anderson, Indiana 46016
773
mi
from 02139
Anderson, IN
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Novartis Investigative site
Boston, Massachusetts 02118
2
mi
from 02139
Boston, MA
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Novartis Investigative Site
Bristol, Connecticut 06010
106
mi
from 02139
Bristol, CT
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Novartis Investigative Site
Butte, Montana 59701
2044
mi
from 02139
Butte, MT
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Novartis Investigative Site
Camp Hill, Pennsylvania 17011
335
mi
from 02139
Camp Hill, PA
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Novartis Investigational Site
Charleston, South Carolina 29407
818
mi
from 02139
Charleston, SC
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Novartis Investigator Site
Chicago, Illinois 60612
849
mi
from 02139
Chicago, IL
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Novartis Investigative Site
Cincinnati, Ohio 45229
733
mi
from 02139
Cincinnati, OH
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Novartis Investigator Site
Clearwater, Florida 33756
1192
mi
from 02139
Clearwater, FL
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Novartis Investigative Site
Columbus, Ohio 43205
638
mi
from 02139
Columbus, OH
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Novartis Investigative Site
Danbury, Connecticut 06810
138
mi
from 02139
Danbury, CT
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Novartis Investigative Site
Danbury, Connecticut 06810
138
mi
from 02139
Danbury, CT
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Novartis Investigative Site
Decatur, Georgia 30030
929
mi
from 02139
Decatur, GA
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Novartis
Denver, Colorado 80262
1760
mi
from 02139
Denver, CO
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Novartis Investigative Site
Durham, North Carolina 27710
607
mi
from 02139
Durham, NC
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Novartis Investigative Site
Hagerstown, Maryland 21742
392
mi
from 02139
Hagerstown, MD
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Novartis Investigative Site
Hartford, Connecticut 06106
90
mi
from 02139
Hartford, CT
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Novartis Investigative Site
Houston, Texas 77030
1605
mi
from 02139
Houston, TX
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Novartis Investigative Site
Idaho Falls, Idaho 83404
2051
mi
from 02139
Idaho Falls, ID
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Novartis Investigative Site
Jacksonville, Florida 32216
1015
mi
from 02139
Jacksonville, FL
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Novartis Investigative Site
Jacksonville, North Carolina 28546
626
mi
from 02139
Jacksonville, NC
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Novartis Investigative Site
Kalamazoo, Michigan 49048
738
mi
from 02139
Kalamazoo, MI
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Novartis Investigative Site
Knoxville, Tennessee 37934
815
mi
from 02139
Knoxville, TN
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Novartis Investigative site
Los Angeles, California 90095
2599
mi
from 02139
Los Angeles, CA
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Novartis Investigative Site
Michigan City, Indiana 46360
810
mi
from 02139
Michigan City, IN
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Novartis Investigative Site
Newark, Delaware 19713
305
mi
from 02139
Newark, DE
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Novartis Investigative Site
Ogden, Utah 84405
2088
mi
from 02139
Ogden, UT
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Novartis Investigative Site
Oklahoma City, Oklahoma 73104
1489
mi
from 02139
Oklahoma City, OK
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Novartis Investigative Site
Palm Desert, California 92211
2503
mi
from 02139
Palm Desert, CA
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Novartis
San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
1764
mi
from 02139
San Antonio, TX
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Novartis Investigator Site
Topeka, Kansas 66606
1304
mi
from 02139
Topeka, KS
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Novartis Investigative Site
Troy, Michigan 48098
614
mi
from 02139
Troy, MI
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Novartis Investigative Site
West Reading, Pennsylvania 19611
287
mi
from 02139
West Reading, PA
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