- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01259726
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
May 30, 2021 updated by: Shire
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
173
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aalst, Belgium
-
Brussels, Belgium
-
Leuven, Belgium
-
Liege, Belgium
-
-
-
-
Alberta
-
Calgary, Alberta, Canada
-
-
Ontario
-
Hamilton, Ontario, Canada
-
-
Quebec
-
Chicoutimi, Quebec, Canada
-
Montreal, Quebec, Canada
-
Trois-Rivieres, Quebec, Canada
-
-
-
-
-
Hannover, Germany
-
Koln, Germany
-
Leipzig, Germany
-
Wilhelmshaven, Germany
-
-
-
-
Andalucia
-
Sevilla, Andalucia, Spain
-
-
Cataluna
-
Barcelona, Cataluna, Spain
-
-
Communidad De Madrid
-
Majadahonda, Communidad De Madrid, Spain
-
-
-
-
-
Lugano, Switzerland
-
-
-
-
California
-
Modesto, California, United States
-
Palm Desert, California, United States
-
Sacramento, California, United States
-
-
Colorado
-
Aurora, Colorado, United States
-
-
Connecticut
-
Hartford, Connecticut, United States
-
-
Florida
-
Bay Pines, Florida, United States
-
Jacksonville, Florida, United States
-
-
Hawaii
-
Honolulu, Hawaii, United States
-
-
Illinois
-
Chicago, Illinois, United States
-
Maywood, Illinois, United States
-
-
Indiana
-
Anderson, Indiana, United States
-
Lafayette, Indiana, United States
-
-
Kentucky
-
Lexington, Kentucky, United States
-
-
Louisiana
-
New Orleans, Louisiana, United States
-
-
Maryland
-
Chevy Chase, Maryland, United States
-
-
Michigan
-
Detroit, Michigan, United States
-
Grosse Pointe Woods, Michigan, United States
-
Novi, Michigan, United States
-
Royal Oak, Michigan, United States
-
Sault Sainte-Marie, Michigan, United States
-
-
Minnesota
-
Rochester, Minnesota, United States
-
-
Missouri
-
Saint Louis, Missouri, United States
-
-
Montana
-
Butte, Montana, United States
-
-
Nebraska
-
Omaha, Nebraska, United States
-
-
New York
-
Albany, New York, United States
-
Bronx, New York, United States
-
New York, New York, United States
-
North Massapequa, New York, United States
-
Syracuse, New York, United States
-
-
North Carolina
-
Winston-Salem, North Carolina, United States
-
-
Ohio
-
Akron, Ohio, United States
-
Cleveland, Ohio, United States
-
Lima, Ohio, United States
-
Toledo, Ohio, United States
-
-
Pennsylvania
-
Lancaster, Pennsylvania, United States
-
West Reading, Pennsylvania, United States
-
-
Tennessee
-
Memphis, Tennessee, United States
-
-
Texas
-
Houston, Texas, United States
-
Temple, Texas, United States
-
-
Utah
-
Salt Lake City, Utah, United States
-
-
Virginia
-
Winchester, Virginia, United States
-
-
Washington
-
Tacoma, Washington, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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.
- Subjects who are medically stable.
- Subjects who are willing and able to comply with the study procedures and visit schedules outlined.
- If female be post-menopausal, surgically sterile or agree to follow an acceptable method of birth control.
Exclusion Criteria:
- Subjects who have had more than 2 episodes of CDI within the last 6 months.
- Subjects who have been diagnosed with Inflammatory Bowel Disease,active Irritable Bowel Syndrome, celiac disease, active gastroparesis, toxic megacolon.
- GI surgery within 6 weeks before the day of randomization
- Have known immunodeficiency disorder, such as HIV Infection
- Pregnant or breast feeding females.
- Concurrent acute life-threatening diseases.
- Inability to tolerate oral liquids.
- Have an absolute neutrophil count < 1000/mm3 at screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
10 mL placebo once daily for 14 days
|
Experimental: VP20621 Low Dose and Placebo
|
10 mL placebo once daily for 14 days
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days
VP20621 as oral liquid once daily for 14 days
|
Experimental: VP20621 High Dose and Placebo
|
10 mL placebo once daily for 14 days
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days
VP20621 as oral liquid once daily for 14 days
|
Experimental: VP20621 High Dose
|
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days
VP20621 as oral liquid once daily for 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a study participant, regardless of causal relationship.
TEAEs were defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug).
SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement.
|
Baseline up to 7 days after the last dose of study drug (up to Week 3)
|
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
|
After study drug administration period (14 days) through Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Clostridium Difficile Infection (CDI) Recurrence
Time Frame: Baseline (Day 1) up to Week 6
|
CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea case report form (CRF) page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator.
|
Baseline (Day 1) up to Week 6
|
Number of Participants With Use of Antibacterial Treatment for CDI
Time Frame: Baseline (Day 1) up to Week 6
|
Any antibacterial medication used after Day 1 for which the investigator selected the indication "antibacterial for C. difficile infection".
|
Baseline (Day 1) up to Week 6
|
Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools
Time Frame: Baseline (Day 1) up to Week 6
|
Data were derived from all AEs starting on or after Day 1 for which a Diarrhea CRF page was completed.
|
Baseline (Day 1) up to Week 6
|
Time to First CDI Recurrence
Time Frame: Baseline (Day 1) up to Week 6
|
CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea CRF page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator.
Time of onset is from date of randomization to date of first CDI recurrence.
Time to first CDI recurrence was assessed using Kaplan-Meier curve.
Due to small number of subjects (<50%) with CDI recurrence, median time to event was not evaluable.
|
Baseline (Day 1) up to Week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2011
Primary Completion (Actual)
June 11, 2013
Study Completion (Actual)
June 11, 2013
Study Registration Dates
First Submitted
December 9, 2010
First Submitted That Met QC Criteria
December 10, 2010
First Posted (Estimate)
December 14, 2010
Study Record Updates
Last Update Posted (Actual)
June 10, 2021
Last Update Submitted That Met QC Criteria
May 30, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VP20621-200
- 2010-020484-20 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Clostridium Difficile Infection
-
Vedanta Biosciences, Inc.CompletedClostridium Difficile Infection | Clostridium Difficile Infection Recurrence | Clostridium Difficile | CDI | Clostridioides Difficile Infection | Clostridioides Difficile | Clostridioides Difficile Infection RecurrenceUnited States, Canada
-
Vedanta Biosciences, Inc.Not yet recruitingClostridium Difficile Infection Recurrence | Recurrent Clostridium Difficile Infection | Clostridium Difficile | Diarrhea Infectious | CDI | Clostridium Difficile Infections | Clostridioides Difficile Infection | C.Difficile Diarrhea | Clostridioides Difficile Infection Recurrence | C. Diff Infection
-
University of PennsylvaniaTerminatedSevere Clostridium Difficile Infection | Severe-Complicated/Fulminant Clostridium Difficile InfectionUnited States
-
Mikrobiomik Healthcare Company S.L.CompletedRecurrent Clostridium Difficile Infection | Primary Clostridium Difficile InfectionSpain
-
University Health Network, TorontoTerminatedRecurrent Clostridium Difficile Infection | Laboratory Confirmed Clostridium Difficile InfectionCanada
-
University of Wisconsin, MadisonAgency for Healthcare Research and Quality (AHRQ)Enrolling by invitationClostridium Difficile Infection | Clostridium Difficile | C Difficile ColitisUnited States
-
University of North Carolina, Chapel HillNorth Carolina Translational and Clinical Sciences Institute; North Carolina...CompletedClostridium DifficileUnited States
-
MJM BontenUniversiteit Antwerpen; Universitätsklinikum Köln; Da VolterraCompletedClostridium DifficileGermany, Spain, France, Greece, Netherlands, Romania
-
Astellas Pharma Europe Ltd.Cubist Pharmaceuticals LLCTerminatedClostridium DifficileSpain, France, Germany, Greece, Denmark, Austria, Poland
-
Chinese University of Hong KongUnknownClostridium Difficile Infection | Clostridium DifficileHong Kong
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States