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
  Purpose

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.


Condition Intervention Phase
Clostridium Difficile Infection
Biological: VP20621
Other: Placebo
Phase 2

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
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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.


Enrollment: 173
Study Start Date: May 2011
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
10 mL placebo once daily for 14 days
Experimental: VP20621 Low Dose and Placebo Biological: VP20621
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days
Other: Placebo
10 mL placebo once daily for 14 days
Experimental: VP20621 High Dose and Placebo 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
Experimental: VP20621 High Dose Biological: VP20621
VP20621 as oral liquid once daily for 14 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259726

  Show 59 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Steve Villano, MD ViroPharma
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01259726     History of Changes
Other Study ID Numbers: VP20621-200
Study First Received: December 9, 2010
Last Updated: March 19, 2014
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

Keywords provided by Shire:
Diarrhea
Clostridium difficile
Clostridium infections
Signs and Symptoms Digestive
Bacterial Infections
Pharmacologic Actions

Additional relevant MeSH terms:
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 23, 2014