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NCT01037231 · ClinicalTrials.gov registry record · Phase 2
Phase 2/3 Oxabact Study
A Phase 2 study of Primary Hyperoxaluria, sponsored by OxThera.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 3
- Study locations
NCT01037231 is a Phase 2 study of Primary Hyperoxaluria that has completed, run by OxThera. The registered enrollment target is 36 participants, below the 1,211-participant average among 3 other Primary Hyperoxaluria trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT01037231, a Phase 2 study of Primary Hyperoxaluria, has completed, sponsored by OxThera.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 3
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Oxalobacter formigenes
Study Locations (3)
Other
- University Children's Hospital (Division of Pediatric Nephrology) - Cologne
- Academy Medical Center, University of Amsterdam - Amsterdam
Minnesota
- Mayo Clinic (Department of Pediatric Nephrology) - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2009-12 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01037231
The ClinicalTrials.gov registry entry for NCT01037231 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,211-participant average among 3 other Primary Hyperoxaluria trials with a reported enrollment target (97% lower). The listed sponsor is OxThera, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Hyperoxaluria appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01037231 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Other, Minnesota.
Frequently Asked Questions
What is clinical trial NCT01037231 about?
NCT01037231 is a clinical study titled "Phase 2/3 Oxabact Study". The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.
What is the current status of trial NCT01037231?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2009-12. Estimated completion is 2011-01.
What conditions does trial NCT01037231 study?
This clinical trial studies the following conditions: Primary Hyperoxaluria.
What interventions are being tested in trial NCT01037231?
The interventions under investigation include: Placebo (DRUG), Oxalobacter formigenes (BIOLOGICAL).
Who is sponsoring clinical trial NCT01037231?
This trial is sponsored by OxThera, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01037231 being conducted?
This trial has 3 study locations across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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