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 - ND

• Conditions: acute open tibia shaft fractures; MedDRA version: 9.1Level: LLTClassification code 10043827Term: Tibia fracture

• Registration Number: EUCTR2006-005093-40-IT
• Lead Sponsor: KUROS BIOSURGERY AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1)patients with acute open fracture of the tibial shaft secondary to trauma assessed by medical examination and current radiographs indicated for open fracture reduction and internal fracture fixation with osteosynthesis plates or intra-medullary nail
2)soft tissue management (if medically warranted, e.g. debridement, irrigation) within 6 hrs after trauma
3)male and female patients ≥ 18 years
4)body mass index (BMI) 16-33, 50 kg < patient weight < 140 kg
5)females of child-bearing potential must be willing to undergo a pregnancy test prior to treatment start (at screening)
6)females of child-bearing potential must agree to have acceptable contraception for at least 3 months after receiving the study medication I-040202
7)willingness and ability to understand, participate and comply with the study requirements
8)signed Informed Consent Form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)IIIc open fracture according to the Gustilo-Anderson classification
2)tibial defects requiring bone-grafting (e.g. large segmental defects)
3)duration from trauma to surgery longer than 14 days
4)concomitant acute bone injuries and/or major skin or other significant injuries that would interfere with the tibial shaft fracture healing process
5)concomitant ipsilateral tibial fractures other than in the diaphyseal region
6)evidence of immune suppression
7)suspected or known hypersensitivity to the study medication or components of it
8)evidence of hypercalcemia
9)hyperparathyroidism
10)on treatment and/or planned treatment with products containing PTH (e.g. Forteo)
11)pregnant or lactating females
12)participation in another clinical trial within the last 3 months
13)active or past history of malignant tumor
14)history or evidence for any hereditary or acquired chronic bone disease
15)history or evidence for any clinically relevant organ failure or any other relevant medical condition that, in the opinion of the investigator, will relevantly interfere with the assessment of study outcome or will impose hazard to the patient if study therapy will be initiated
16)known history of allergy to anaesthetics

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified