Trials / Completed
CompletedNCT01037231
Phase 2/3 Oxabact Study
A Phase 2/3, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of OxabactTM to Reduce Urinary Oxalate in Subjects With Primary Hyperoxaluria.
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- OxThera · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Oxalobacter formigenes | NLT (not less than) 10\^7 CFU oxalobacter formigenes twice daily for 24 weeks |
| DRUG | Placebo | placebo |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2011-01-01
- Completion
- 2011-01-01
- First posted
- 2009-12-22
- Last updated
- 2013-05-15
Locations
3 sites across 3 countries: United States, Germany, Netherlands
Source: ClinicalTrials.gov record NCT01037231. Inclusion in this directory is not an endorsement.