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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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
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Chicago, Illinois 60612
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Anderson, Indiana 46016
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Anderson, IN
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Boston, Massachusetts 02118
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Bristol, Connecticut 06010
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Butte, Montana 59701
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Camp Hill, Pennsylvania 17011
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Charleston, South Carolina 29407
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Cincinnati, Ohio 45229
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Clearwater, Florida 33756
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Columbus, Ohio 43205
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Columbus, OH
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Danbury, Connecticut 06810
1317
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Danbury, Connecticut 06810
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Decatur, Georgia 30030
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Decatur, GA
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Denver, Colorado 80262
407
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Durham, North Carolina 27710
1048
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Hagerstown, Maryland 21742
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Hartford, Connecticut 06106
1358
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Houston, Texas 77030
572
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Houston, TX
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Idaho Falls, Idaho 83404
841
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Idaho Falls, ID
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Jacksonville, Florida 32216
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Jacksonville, North Carolina 28546
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Kalamazoo, Michigan 49048
718
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Knoxville, Tennessee 37934
777
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Los Angeles, California 90095
1177
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Los Angeles, CA
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Michigan City, Indiana 46360
641
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Mineola, New York 11501
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Newark, Delaware 19713
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Ogden, Utah 84405
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Oklahoma City, Oklahoma 73104
158
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Palm Desert, California 92211
1074
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
576
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Topeka, Kansas 66606
145
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Topeka, KS
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Troy, Michigan 48098
841
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West Reading, Pennsylvania 19611
1184
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West Reading, PA
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