Phase 2/3 Oxabact Study
NCT01037231 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2013-05-15
Summary
The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.
Conditions
- Primary Hyperoxaluria
Interventions
- BIOLOGICAL
-
Oxalobacter formigenes
NLT (not less than) 10\^7 CFU oxalobacter formigenes twice daily for 24 weeks
- DRUG
-
placebo
Sponsors & Collaborators
-
OxThera
lead INDUSTRY
Principal Investigators
-
Dawn Milliner, M.D. · Mayo Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-12-31
- Primary Completion
- 2011-01-31
- Completion
- 2011-01-31
Countries
- United States
- Germany
- Netherlands
Study Locations
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