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Phase III Study of Chondrocyte Alginate Gel Suspension in Pediatric Patients With Vesicoureteral Reflux

NCT00004487 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-03-25

No results posted yet for this study

Summary

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.

Conditions

  • Vesicoureteral Reflux

Interventions

DRUG

chondrocyte-alginate gel suspension

Sponsors & Collaborators

  • Curis, Inc.

    collaborator INDUSTRY

  • FDA Office of Orphan Products Development

    lead FED

Principal Investigators

  • Frank T. Gentile · Curis, Inc.

Study Design

Purpose
TREATMENT

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-05-31

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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 NCT00004487 on ClinicalTrials.gov