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Adjunctive Therapy to Treat Tibial Shaft Fractures

NCT00533793 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2012-03-16

No results posted yet for this study

Summary

A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group, international multi-center study. The study will consist of four treatment groups - one control group (SoC) and three I-040202 groups receiving SoC plus 0.133 mg/mL, 0.4 mg/mL or 1.0 mg/mL I-040202.

Conditions

Interventions

PROCEDURE

open fracture reduction

internal fracture fixation: osteosynthesis plates or intra-medullary nails

Sponsors & Collaborators

  • Baxter BioScience

    collaborator INDUSTRY

  • Kuros Biosurgery AG

    lead INDUSTRY

Principal Investigators

  • Virginia Jamieson, MD · Kuros Biosurgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Bulgaria
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Romania
  • Serbia
  • Slovakia
  • Slovenia
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT00533793 on ClinicalTrials.gov