Trials / Completed
CompletedNCT02012985
Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Patients With Primary Hyperoxaluria
A Phase 1/2, Randomised, Placebo-controlled, Double-blind, Multi-centre Study to Evaluate the Efficacy and Safety of OC5 to Reduce Urinary Oxalate in Subjects With Primary Hyperoxaluria
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 28 (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 | Oxabact OC5 capsules | The dose will be not less than (NLT) 1E+09 colony forming units (CFU) twice daily for 8 to 10 weeks. The dose (an enteric-coated size 4 capsule) will be administered orally with breakfast and dinner. |
| DRUG | Placebo capsules | An enteric-coated placebo capsule manufactured to mimic the OC5 capsule. The capsule will be administered orally with breakfast and dinner twice daily for 8 to 10 weeks. |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2015-01-01
- Completion
- 2015-01-01
- First posted
- 2013-12-17
- Last updated
- 2015-10-16
Locations
8 sites across 3 countries: France, Germany, United Kingdom
Source: ClinicalTrials.gov record NCT02012985. Inclusion in this directory is not an endorsement.