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

Novartis

Status and phase: Completed; Phase 2

Conditions: Moderate Clostridium Difficile Infection

Treatments: Drug: LFF571; Drug: Vancomycin (POC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01232595

2011-000947-26

CLFF571X2201

Details and patient eligibility

About

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

Enrollment: 109 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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109 participants in 6 patient groups

LFF571 (POC)

Experimental group

Treatment:

Drug: LFF571

Vancomycin (POC)

Active Comparator group

Treatment:

Drug: Vancomycin (POC)

LFF571 Dose level 1 (cohort 2)

Experimental group

Treatment:

Drug: LFF571

LFF571 Dose level 2 (cohort 2)

Experimental group

Treatment:

Drug: LFF571

LFF571 Dose level 3 (cohort 2)

Experimental group

Treatment:

Drug: LFF571

LFF571 Dose level 4 (cohort 2)

Experimental group

Treatment:

Drug: LFF571