CompletedPhase 2

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

United States109 participantsStarted 2010-10

Plain-language summary

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

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

POC: Difference in clinical response rate of LFF571 compared to vancomycin in patients with moderate C. difficile infections at day 12/13.

Timeframe: Day 12/13

POC: Safety and tolerability of LFF571

Timeframe: Day 12/13

POC:Clinical response rates (clinical cure) of patients with moderate C. difficile infections to different LFF571 dose regimens and total daily doses (cohort 2).

Timeframe: Day 12/13

Cohort 2: Clinical response rate (clinical cure) of LFF571 in patients with mild and moderate C. difficile infections to different LFF571 dose regimens and total daily doses administered orally for 10 days

Timeframe: Day 12/13

Cohort 2: Dose-response relationship of different dose regimens and total daily dose s of LFF571

Timeframe: Day 12/13

Cohort 2: Safety and tolerability of LFF571 dose regimens and total daily doses administered orally for 10 days to C. difficile infected patients.

Timeframe: Day 12/13

Trial details

NCT IDNCT01232595

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-07

View on ClinicalTrials.gov More Moderate Clostridium Difficile Infection trials

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

POC: Difference in clinical response rate of LFF571 compared to vancomycin in patients with moderate C. difficile infections at day 12/13.

Timeframe: Day 12/13

POC: Safety and tolerability of LFF571

Timeframe: Day 12/13

POC:Clinical response rates (clinical cure) of patients with moderate C. difficile infections to different LFF571 dose regimens and total daily doses (cohort 2).

Timeframe: Day 12/13

Cohort 2: Dose-response relationship of different dose regimens and total daily dose s of LFF571

Timeframe: Day 12/13

Cohort 2: Safety and tolerability of LFF571 dose regimens and total daily doses administered orally for 10 days to C. difficile infected patients.

Timeframe: Day 12/13