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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01259726
First received: December 9, 2010
Last updated: March 19, 2014
Last verified: March 2014

December 9, 2010
March 19, 2014
May 2011
June 2013   (final data collection date for primary outcome measure)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Any AE that begins during study drug treatment period and up to 7 days after the last dose of study drug.
Same as current
Complete list of historical versions of study NCT01259726 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of VP 20621 for Prevention of Recurrence of Clostridium Difficile Infection (CDI) in Adults Previously Treated for CDI

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Clostridium Difficile Infection
  • 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
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Experimental: VP20621 Low Dose and Placebo
    Interventions:
    • Biological: VP20621
    • Other: Placebo
  • Experimental: VP20621 High Dose and Placebo
    Interventions:
    • Biological: VP20621
    • Other: Placebo
  • Experimental: VP20621 High Dose
    Intervention: Biological: VP20621
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
173
July 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Adult subjects, 18 years of age and over, who understand the risks and benefits of participation and have provided written informed consent for the study.
  2. Subjects who are experiencing a first event or first recurrence of clostridium difficile (CDI) within the last 28 days and have been successfully treated with an antibiotic for CDI.
  3. Subjects who are medically stable.
  4. Subjects who are willing and able to comply with the study procedures and visit schedules outlined.
  5. If female be post-menopausal, surgically sterile or agree to follow an acceptable method of birth control.

Exclusion Criteria:

  1. Subjects who have had more than 2 episodes of CDI within the last 6 months.
  2. Subjects who have been diagnosed with Inflammatory Bowel Disease,active Irritable Bowel Syndrome, celiac disease, active gastroparesis, toxic megacolon.
  3. GI surgery within 6 weeks before the day of randomization
  4. Have known immunodeficiency disorder, such as HIV Infection
  5. Pregnant or breast feeding females.
  6. Concurrent acute life-threatening diseases.
  7. Inability to tolerate oral liquids.
  8. Have an absolute neutrophil count < 1000/mm3 at screening
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Germany,   Spain,   Switzerland
 
NCT01259726
VP20621-200
Yes
Shire
Shire
Not Provided
Study Director: Steve Villano, MD ViroPharma
Shire
March 2014

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