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

Completed · Phase 2

Conditions studied: Moderate Clostridium Difficile Infection

In brief

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

Key facts

Study ID

NCT01232595

Run by

Novartis Pharmaceuticals

People needed

109

Starts

2010-10-01

Expected to finish

2013-07-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Palm Desert, California, United States
• Novartis Investigative Site — Bristol, Connecticut, United States
• Novartis Investigative Site — Clearwater, Florida, United States
• Novartis Investigative Site — Decatur, Georgia, United States
• Novartis Investigative Site — Idaho Falls, Idaho, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Michigan City, Indiana, United States
• Novartis Investigative Site — Topeka, Kansas, United States
• Novartis Investigative Site — Butte, Montana, United States
• Novartis Investigative Site — Durham, North Carolina, United States
• Novartis Investigative Site — Columbus, Ohio, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Charleston, South Carolina, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Hamilton, Ontario, Canada
• Novartis Investigative Site — Chicoutimi, Quebec, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Trois-Rivières, Quebec, Canada

Full record on ClinicalTrials.gov

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