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Sponsors and Collaborators: |
Kuros Biosurgery AG Baxter BioScience |
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Information provided by: | Kuros Biosurgery AG |
ClinicalTrials.gov Identifier: | NCT00533793 |
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.
Condition | Intervention | Phase |
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Trauma |
Procedure: open fracture reduction |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Randomized, Controlled, Open-Labeled (Dose-Blinded) Dose Finding Study of the Safety and Efficacy of I-040202 in the Treatment of Patients With Acute Open Tibial Shaft Fractures |
Estimated Enrollment: | 200 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SoC: Active Comparator
Standard of Care
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Procedure: open fracture reduction
internal fracture fixation: osteosynthesis plates or intra-medullary nails
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SoC plus 0.133 mg/mL: Active Comparator |
Procedure: open fracture reduction
internal fracture fixation: osteosynthesis plates or intra-medullary nails
|
SoC plus 0.4 mg/mL: Active Comparator |
Procedure: open fracture reduction
internal fracture fixation: osteosynthesis plates or intra-medullary nails
|
SoC plus 1.0 mg/mL: Active Comparator |
Procedure: open fracture reduction
internal fracture fixation: osteosynthesis plates or intra-medullary nails
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
females of child-bearing potential must agree to have acceptable contraception for at least 3 months after receiving the study medication I-040202
Acceptable contraceptive measures are:
Exclusion Criteria:
Contact: Kuros Biosurgery | +41 44 200 5600 | info@kuros.ch |
Responsible Party: | Kuros Biosurgery ( Virginia Jamieson ) |
Study ID Numbers: | CS I-040202/01 |
Study First Received: | September 20, 2007 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00533793 |
Health Authority: | Switzerland: Swissmedic; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Czech Republic: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Romania: National Medicines Agency; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Slovakia: State Institute for Drug Control; Slovenia: Agency for Medicinal Products - Ministry of Health; Finland: National Agency for Medicines |
bone, tibial shaft fracture |
Signs and Symptoms Fractures, Bone Wounds and Injuries |