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Study to Evaluate the Efficacy and Safety of OxabactTM on Reduction of Urinary Oxalate in Primary Hyperoxaluria Patients

NCT00638703 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2013-05-15

No results posted yet for this study

Summary

The main 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
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-09-30
Completion
2008-10-31

Countries

  • United States

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 NCT00638703 on ClinicalTrials.gov