Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 3/1/2014 |
| Start Date: | June 2012 |
| End Date: | January 2014 |
| Contact: | Mara Lee |
| Email: | maralee@optimerpharma.com |
| Phone: | 858-427-3298 |
A Phase 2A, Multi-Center, Open-Label, Uncontrolled Study to Determine the Safety, Tolerability, and Pharmacokinetics of Fidaxomicin Oral Suspension or Tablets in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of
fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).
fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).
Inclusion Criteria:
- Male or female 6 months to 17 years 11 months of age, inclusive;
- Female subjects of childbearing potential must use adequate contraception
- Diagnosed with CDAD
Exclusion Criteria:
- Concurrent use of oral vancomycin or metronidazole or any other effective treatments
for CDAD
- Fulminant colitis
- History of inflammatory bowel disease
- Pregnant or breast-feeding
- Need for concurrent use of some P-glycoprotein inhibitors during therapy
We found this trial at
14
sites
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