Trial record 1 of 1 for:    VP 20621
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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: February 11, 2015
Last verified: March 2014
Results First Received: January 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Clostridium Difficile Infection
Interventions: Biological: VP20621
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at a total of 44 investigative sites [United states (US)=33, Canada=4, and Europe=7], and 3 of the 33 US sites did not enroll any participants (each had 1 screen failure).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 213 participants formally screened to participate in this study, 168 participants were treated. Five participants were randomized but not treated and 40 participants were screen failures.

Reporting Groups
  Description
Placebo Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
VP 20621 Low Dose and Placebo VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
VP 20621 High Dose and Placebo VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
VP 20621 High Dose VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.

Participant Flow:   Overall Study
    Placebo     VP 20621 Low Dose and Placebo     VP 20621 High Dose and Placebo     VP 20621 High Dose  
STARTED     43     41     43     41  
Treated     40     37     41     39  
COMPLETED     38     37     39     36  
NOT COMPLETED     5     4     4     5  
Death                 1                 0                 0                 0  
Physician Decision                 2                 0                 1                 1  
Withdrawal by Subject                 1                 3                 2                 1  
Lost to Follow-up                 1                 1                 1                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat-Safety (ITT-S) population was defined as all randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Placebo Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
VP 20621 Low Dose and Placebo VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
VP 20621 High Dose and Placebo VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
VP 20621 High Dose VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
Total Total of all reporting groups

Baseline Measures
    Placebo     VP 20621 Low Dose and Placebo     VP 20621 High Dose and Placebo     VP 20621 High Dose     Total  
Number of Participants  
[units: participants]
  43     41     43     41     168  
Age  
[units: years]
Mean (Standard Deviation)
  54.7  (19.19)     58.2  (14.42)     57.2  (18.46)     60.6  (16.4)     57.6  (17.2)  
Gender  
[units: participants]
         
Female     26     26     24     28     104  
Male     17     15     19     13     64  



  Outcome Measures
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1.  Primary:   Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 7 days after the last dose of study drug (up to Week 3) ]

2.  Primary:   Number of Participants With Positive Clostridium Difficile Stool Cultures Demonstrating Non-Toxigenic Clostridium Difficile-Strain M3   [ Time Frame: After study drug administration period (14 days) through Week 6 ]

3.  Secondary:   Number of Participants With Clostridium Difficile Infection (CDI) Recurrence   [ Time Frame: Baseline (Day 1) up to Week 6 ]

4.  Secondary:   Number of Participants With Use of Antibacterial Treatment for CDI   [ Time Frame: Baseline (Day 1) up to Week 6 ]

5.  Secondary:   Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools   [ Time Frame: Baseline (Day 1) up to Week 6 ]

6.  Secondary:   Time to First CDI Recurrence   [ Time Frame: Baseline (Day 1) up to Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Physician
Organization: Shire
phone: 1 866-842-5335


No publications provided by Shire

Publications automatically indexed to this study:

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01259726     History of Changes
Other Study ID Numbers: VP20621-200, 2010-020484-20
Study First Received: December 9, 2010
Results First Received: January 20, 2015
Last Updated: February 11, 2015
Health Authority: United States: Food and Drug Administration
Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Ethics Commission
Germany: Paul-Ehrlich-Institut
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica
Switzerland: Ethikkommission
Switzerland: Swissmedic