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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01232595
First Posted: November 2, 2010
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
November 1, 2010
November 2, 2010
March 25, 2015
October 2010
July 2013   (Final data collection date for primary outcome measure)
  • POC: Difference in clinical response rate of LFF571 compared to vancomycin in patients with moderate C. difficile infections at day 12/13. [ Time Frame: Day 12/13 ]
  • POC: Safety and tolerability of LFF571 [ Time Frame: Day 12/13 ]
    Safety assessments will include vital signs, laboratory tests, electrocardiograms (ECG), pharmacokinetic (PK) samples and adverse events. (Cohorts 1 and 2)
  • POC:Clinical response rates (clinical cure) of patients with moderate C. difficile infections to different LFF571 dose regimens and total daily doses (cohort 2). [ Time Frame: Day 12/13 ]
    Clinical cure is resolution or improvement of symptoms and signs of C. difficile infection such that additional or alternative antimicrobial therapy or other theraperutic intervention is not needed. In addition, patient must have absence of fever for two consecutive days and <3 non-lliquid stools per day for two consecutive days
  • 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 [ Time Frame: Day 12/13 ]
    Clinical cure is resolution or improvement of symptoms and signs of C. difficile infection such that additional or alternative antimicrobial therapy or other theraperutic intervention is not needed. In addition, patient must have absence of fever for two consecutive days and <3 non-lliquid stools per day for two consecutive days.
  • Cohort 2: Dose-response relationship of different dose regimens and total daily dose s of LFF571 [ Time Frame: 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. [ Time Frame: Day 12/13 ]
    Safety assessments will include vital signs, laboratory tests, electrocardiograms (ECG), pharmacokinetic (PK) samples and adverse events.
  • To evaluate the difference in clinical response rate of LFF571 compared to vancomycin in patients with moderate C. difficile infections [ Time Frame: End of therapy ]
  • To assess the safety and tolerability of LFF571 (assessed by vital signs, laboratory tests, electrocardiograms (ECG), pharmacokinetic (PK) samples and adverse events) [ Time Frame: End of therapy ]
Complete list of historical versions of study NCT01232595 on ClinicalTrials.gov Archive Site
  • POC: To evaluate the time to resolution of diarrhea during the treatment period for LFF571-treated patients (cohorts 1 and 2) [ Time Frame: End of therapy ]
  • POC: To evaluate the relapse rate within 30 days following completion of LFF571-treated patients (cohort 1) [ Time Frame: 30 days ]
  • POC: To evaluate the sustained response and relapse rate within 30 days following completion of different oral LFF571 dose regimens (cohort 2) [ Time Frame: 30 days ]
  • POC: To evaluate the fecal concentrations of LFF571 following different LFF571 dose regimens (cohort 2) [ Time Frame: 30 days ]
  • POC: To evaluate the serum concentrations of LFF571 following different LFF571 dose regimens. (cohort 2) [ Time Frame: 30 days ]
  • Cohort 2: Time to resolution of diarrhea during the treatment period for oral LFF571 in C. difficile infected patients. [ Time Frame: Day 12/13 ]
  • Cohort 2: Serum concentrations of oral LFF571 following different dose regimens in C. difficile infected patients. [ Time Frame: Day 12/13 ]
  • Cohort 2: Fecal concentrations of LFF571 following different oral LFF571 dose regimens in C. Difficile infected patients. [ Time Frame: Day 12/13 ]
  • Cohort 2: Sustained response (sustained clinical cure) rate and clinical relapse rate at 30 days following completion of different oral LFF571 dose regimens. [ Time Frame: 30 days ]
    Clinical cure is resolution or improvement of symptoms and signs of C. difficile infection such that additional or alternative antimicrobial therapy or other theraperutic intervention is not needed. In addition, patient must have absence of fever for two consecutive days and <3 non-lliquid stools per day for two consecutive days
  • To evaluate the time to resolution of diarrhea during the treatment period for LFF571-treated patients [ Time Frame: End of therapy ]
  • Measure: To evaluate the relapse rate within 30 days following completion of LFF571-treated patients [ Time Frame: 30 days ]
Not Provided
Not Provided
 
Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Moderate Clostridium Difficile Infection
  • Drug: LFF571
  • Drug: Vancomycin (POC)
  • Experimental: LFF571 (POC)
    Intervention: Drug: LFF571
  • Active Comparator: Vancomycin (POC)
    Intervention: Drug: Vancomycin (POC)
  • Experimental: LFF571 Dose level 1 (cohort 2)
    Intervention: Drug: LFF571
  • Experimental: LFF571 Dose level 2 (cohort 2)
    Intervention: Drug: LFF571
  • Experimental: LFF571 Dose level 3 (cohort 2)
    Intervention: Drug: LFF571
  • Experimental: LFF571 Dose level 4 (cohort 2)
    Intervention: Drug: LFF571

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
July 2013
July 2013   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
Hungary,   Spain
 
NCT01232595
CLFF571X2201
2011-000947-26
No
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP