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

Use our guide to learn which trials are right for you!

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
West Reading, Pennsylvania 19611
?
mi
from
West Reading, PA
Click here to add this to my saved trials
Novartis Investigative Site
Anderson, Indiana 46016
?
mi
from
Anderson, IN
Click here to add this to my saved trials
Novartis Investigative site
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
Novartis Investigative Site
Bristol, Connecticut 06010
?
mi
from
Bristol, CT
Click here to add this to my saved trials
Novartis Investigative Site
Butte, Montana 59701
?
mi
from
Butte, MT
Click here to add this to my saved trials
Novartis Investigative Site
Camp Hill, Pennsylvania 17011
?
mi
from
Camp Hill, PA
Click here to add this to my saved trials
Novartis Investigational Site
Charleston, South Carolina 29407
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Novartis Investigator Site
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Novartis Investigative Site
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Novartis Investigator Site
Clearwater, Florida 33756
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Novartis Investigative Site
Columbus, Ohio 43205
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Novartis Investigative Site
Danbury, Connecticut 06810
?
mi
from
Danbury, CT
Click here to add this to my saved trials
Novartis Investigative Site
Danbury, Connecticut 06810
?
mi
from
Danbury, CT
Click here to add this to my saved trials
Novartis Investigative Site
Decatur, Georgia 30030
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Novartis
Denver, Colorado 80262
?
mi
from
Denver, CO
Click here to add this to my saved trials
Novartis Investigative Site
Durham, North Carolina 27710
?
mi
from
Durham, NC
Click here to add this to my saved trials
Novartis Investigative Site
Hagerstown, Maryland 21742
?
mi
from
Hagerstown, MD
Click here to add this to my saved trials
Novartis Investigative Site
Hartford, Connecticut 06106
?
mi
from
Hartford, CT
Click here to add this to my saved trials
Novartis Investigative Site
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Novartis Investigative Site
Idaho Falls, Idaho 83404
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Novartis Investigative Site
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Novartis Investigative Site
Jacksonville, North Carolina 28546
?
mi
from
Jacksonville, NC
Click here to add this to my saved trials
Novartis Investigative Site
Kalamazoo, Michigan 49048
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
Novartis Investigative Site
Knoxville, Tennessee 37934
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Novartis Investigative site
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Novartis Investigative Site
Michigan City, Indiana 46360
?
mi
from
Michigan City, IN
Click here to add this to my saved trials
Novartis Investigative Site
Mineola, New York 11501
?
mi
from
Mineola, NY
Click here to add this to my saved trials
Novartis Investigative Site
Newark, Delaware 19713
?
mi
from
Newark, DE
Click here to add this to my saved trials
Novartis Investigative Site
Ogden, Utah 84405
?
mi
from
Ogden, UT
Click here to add this to my saved trials
Novartis Investigative Site
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Novartis Investigative Site
Palm Desert, California 92211
?
mi
from
Palm Desert, CA
Click here to add this to my saved trials
Novartis
San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Novartis Investigator Site
Topeka, Kansas 66606
?
mi
from
Topeka, KS
Click here to add this to my saved trials
Novartis Investigative Site
Troy, Michigan 48098
?
mi
from
Troy, MI
Click here to add this to my saved trials