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Phase III Study of Chondrocyte Alginate Gel Suspension in Pediatric Patients With Vesicoureteral Reflux
OBJECTIVES: I. Determine the safety and efficacy of chondrocyte alginate gel suspension in pediatric patients with vesicoureteral reflux. II. Determine the long term efficacy of this treatment regimen in this patient population. III. Evaluate the short and long term avoidance of surgery or antibiotic therapy after this treatment regimen in this patient population. IV. Estimate the risk:benefit ratio of this treatment regimen in these patients.
Details
| Lead sponsor | FDA Office of Orphan Products Development |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 60 |
| Start date | 1999-05 |
Conditions
- Vesicoureteral Reflux
Interventions
- chondrocyte-alginate gel suspension