Status:
COMPLETED
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
Lead Sponsor:
Shire
Conditions:
Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 dur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 27 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2013
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT01259726
Start Date
June 27 2011
End Date
June 11 2013
Last Update
June 10 2021
Active Locations (59)
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1
Modesto, California, United States
2
Palm Desert, California, United States
3
Sacramento, California, United States
4
Aurora, Colorado, United States