Phase 2/3 Oxabact Study

NCT01037231 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-05-15

No results posted yet for this 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

  • Primary Hyperoxaluria

Interventions

BIOLOGICAL

Oxalobacter formigenes

NLT (not less than) 10\^7 CFU oxalobacter formigenes twice daily for 24 weeks

DRUG

Placebo

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

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01037231 on ClinicalTrials.gov