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Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone in Tibia Fractures

Bone Fracture Clinical Trial

Official title:
A Multi-centre, Randomised, Double-blind, Placebocontrolled, Parallel-group Trial Investigating the Efficacy and Safety of Norditropin® SimpleXx® in Tibia Fractures

Clinical Trial 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 of tibia fractures. The trial will be conducted in two parts: in the first part, the patients will be evaluated with regard to efficacy (fracture healing) and safety at short time intervals until week 24 post-surgery. In the second part, long-term safety and fracture healing up to 12 months post-surgery will be evaluated.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00254514
Study type Interventional
Source Novo Nordisk A/S
Contact
Status Completed
Phase Phase 2
Start date August 2001
Completion date October 2003
View Details
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