Status:
COMPLETED
Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Moderate Clostridium Difficile Infection
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in patients who have moderate Clostridium difficile infections.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT01232595
Start Date
October 1 2010
End Date
July 1 2013
Last Update
December 19 2020
Active Locations (18)
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1
Novartis Investigative Site
Palm Desert, California, United States, 92211
2
Novartis Investigative Site
Bristol, Connecticut, United States, 06010
3
Novartis Investigative Site
Clearwater, Florida, United States, 33756
4
Novartis Investigative Site
Decatur, Georgia, United States, 30030