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Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection

NCT01259726 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2021-06-10

Study results available
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Summary

The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a dose regimen of VP 20621 to be used in future studies.

Conditions

  • Clostridium Difficile Infection

Interventions

BIOLOGICAL

VP20621

VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days

BIOLOGICAL

VP20621

VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days

OTHER

Placebo

10 mL placebo once daily for 14 days

BIOLOGICAL

VP20621

VP20621 as oral liquid once daily for 14 days

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-27
Primary Completion
2013-06-11
Completion
2013-06-11

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01259726 on ClinicalTrials.gov