Status:
COMPLETED
Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone in Tibia Fractures
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Bone Fracture
Tibia Fractures
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This trial is conducted in Africa, Europe and Middle East. This trial investigates the efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to placebo in the treatment...
Eligibility Criteria
Inclusion
- Primary surgical treatment of tibia fracture using intramedullary nailing
- Closed fractures: Tscherne Type C1, C2 and C3
- Open fractures: Gustilo Grade I, II and IIIa
Exclusion
- Open growth plate on X-rays
- Known chronic endocrine or metabolic disease including diabetes and severe obesity defined as body mass index (BMI)1 \> 32.0
- Severe head injury defined as patients who are stuporous or comatose with pupillary enlargement or asymmetry
- Critically ill patients defined as patients in need of mechanical ventilation (except during surgical procedures) or circulatory support (defined as use of inotropic drugs)
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2003
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT00254514
Start Date
August 1 2001
End Date
October 1 2003
Last Update
January 23 2017
Active Locations (40)
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1
Novo Nordisk Investigational Site
Kuopio, Finland, 70211
2
Novo Nordisk Investigational Site
Oulu, Finland, 90029
3
Novo Nordisk Investigational Site
Strasbourg, France, 67400
4
Novo Nordisk Investigational Site
Augsburg, Germany, 86156