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

Completed · Phase 2 · Has a placebo group

Conditions studied: Clostridium Difficile Infection

In brief

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.

Key facts

Study ID

NCT01259726

Run by

Shire

People needed

173

Starts

2011-06-27

Expected to finish

2013-06-11

Last updated by the study team

2021-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Palm Desert, California, United States
• Study site — Sacramento, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Bay Pines, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Chicago, Illinois, United States
• Study site — Maywood, Illinois, United States
• Study site — Anderson, Indiana, United States
• Study site — Lafayette, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Chevy Chase, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Grosse Pointe Woods, Michigan, United States
• Study site — Novi, Michigan, United States
• Study site — Royal Oak, Michigan, United States
• Study site — Sault Ste. Marie, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Butte, Montana, United States
• Study site — Omaha, Nebraska, United States
• Study site — Albany, New York, United States
• Study site — Modesto, California, United States

Full record on ClinicalTrials.gov

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