NCT00254514

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Fracture
• Tibia Fractures

Interventions

Type	Name	Description
DRUG	somatropin

Timeline

• Start date: 2001-08-01
• Primary completion: 2003-10-01
• Completion: 2003-10-01
• First posted: 2005-11-16
• Last updated: 2017-01-23

Locations

40 sites across 9 countries: Finland, France, Germany, Hungary, Israel, Norway, Poland, South Africa, Spain