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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00254514
First received: November 15, 2005
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Bone Fracture
Tibia Fractures
Drug: somatropin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomised, Double-blind, Placebocontrolled, Parallel-group Trial Investigating the Efficacy and Safety of Norditropin® SimpleXx® in Tibia Fractures

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Time from surgery until fracture has healed [ Time Frame: During a 12 month period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator's assessment: fracture healed [ Designated as safety issue: No ]
  • Number of fractures healed [ Designated as safety issue: No ]

Enrollment: 407
Study Start Date: August 2001
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254514

Locations
Finland
Oulu, Finland, 90029
France
Strasbourg, France, 67400
Germany
Berlin, Germany, 13353
Hungary
Gyor, Hungary, 9024
Israel
Beer Sheva, Israel, 84101
Norway
Oslo, Norway, 0407
Poland
Gorzów, Poland, 66-400
South Africa
Cape Town, Western Cape, South Africa, 7925
Spain
Valencia, Spain, 46026
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Anders Dejgaard, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00254514     History of Changes
Other Study ID Numbers: NN1606-1365
Study First Received: November 15, 2005
Last Updated: November 18, 2013
Health Authority: South Africa: Medicines Control Council
Israel: Israeli Health Ministry Pharmaceutical Administration
Germany: German Agency of Medicines

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on April 22, 2014