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

This study is currently recruiting participants.
Verified January 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01232595
First received: November 1, 2010
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Moderate Clostridium Difficile Infection
 Drug: LFF571 (cohort 1)
Drug: Vancomycin (cohort 1)
Drug: LFF571 (cohort 2)
Drug: LFF571
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To evaluate the difference in clinical response rate of LFF571 compared to vancomycin in patients with moderate C. difficile infections. Difference in clinical response at the end-of-therapy between the LFF571- and vancomycin-treated patients (cohort 1) [ Time Frame: End of therapy ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of LFF571. Safety assessments will include vital signs, laboratory tests, electrocardiograms (ECG), pharmacokinetic (PK) samples and adverse events. (Cohorts 1 and 2) [ Time Frame: End of therapy ] [ Designated as safety issue: Yes ]
  • To evaluate the clinical response rates of patients with moderate C. difficile infections to different LFF571 dose regimens and total daily doses (cohort 2). [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Measure: To evaluate the relapse rate within 30 days following completion of LFF571-treated patients (cohort 1) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the fecal concentrations of LFF571 following different LFF571 dose regimens (cohort 2) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • To evaluate the serum concentrations of LFF571 following different LFF571 dose regimens. (cohort 2) [ Time Frame: Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: October 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LFF571 (cohort 1) Drug: LFF571 (cohort 1)
Active Comparator: Vancomycin (cohort 1) Drug: Vancomycin (cohort 1)
Experimental: LFF571 Dose level 1 (cohort 2) Drug: LFF571 (cohort 2)
Experimental: LFF571 Dose level 2 (cohort 2) Drug: LFF571 (cohort 2)
Experimental: LFF571 Dose level 3 (cohort 2) Drug: LFF571
Experimental: LFF571 Dose level 4 (cohort 2) Drug: LFF571

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232595

Contacts
Contact: Novartis Pharmaceuticals +1 862 778 8300

  Show 27 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01232595     History of Changes
Other Study ID Numbers: CLFF571X2201
Study First Received: November 1, 2010
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Novartis:
Clostridium difficile,
C. difficile,
CDI,
Clostridium difficile-associated disease,
 CDAD,
pseudomembranous colitis,
PMC,
antibiotic-associated diarrhea

Additional relevant MeSH terms:
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013