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

January 20, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

407

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70211
        • Novo Nordisk Investigational Site
      • Oulu, Finland, 90029
        • Novo Nordisk Investigational Site
  • France
      • Strasbourg, France, 67400
        • Novo Nordisk Investigational Site
  • Germany
      • Augsburg, Germany, 86156
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 13353
        • Novo Nordisk Investigational Site
      • Braunschweig, Germany, 38118
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 20246
        • Novo Nordisk Investigational Site
      • Homburg, Germany, 66421
        • Novo Nordisk Investigational Site
      • Ludwigshafen, Germany, 67071
        • Novo Nordisk Investigational Site
      • Mainz, Germany, 55131
        • Novo Nordisk Investigational Site
      • München, Germany, 81366
        • Novo Nordisk Investigational Site
      • Münster, Germany, 48149
        • Novo Nordisk Investigational Site
      • Offenbach, Germany, 63069
        • Novo Nordisk Investigational Site
      • Würzburg, Germany, D-97080
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1076
        • Novo Nordisk Investigational Site
      • Budapest, Hungary, H-1043
        • Novo Nordisk Investigational Site
      • Budapest, Hungary, H-1081
        • Novo Nordisk Investigational Site
      • Budapest, Hungary, H-1125
        • Novo Nordisk Investigational Site
      • Gyor, Hungary, 9024
        • Novo Nordisk Investigational Site
      • Miskolc, Hungary, H-3526
        • Novo Nordisk Investigational Site
      • Veszprém, Hungary, H-8200
        • Novo Nordisk Investigational Site
  • Israel
      • Beer Sheva, Israel, 84101
        • Novo Nordisk Investigational Site
      • Haifa, Israel, 31096
        • Novo Nordisk Investigational Site
      • Jerusalem, Israel, 91120
        • Novo Nordisk Investigational Site
      • Kfar Save, Israel, 44281
        • Novo Nordisk Investigational Site
      • Tel-Aviv, Israel, 64239
        • Novo Nordisk Investigational Site
  • Norway
      • Lillestrøm, Norway, 2004
        • Novo Nordisk Investigational Site
      • Oslo, Norway, 0407
        • Novo Nordisk Investigational Site
  • Poland
      • Gorzów, Poland, 66-400
        • Novo Nordisk Investigational Site
      • Krakow, Poland, 31-826
        • Novo Nordisk Investigational Site
      • Piekary Slaskie, Poland, 41-940
        • Novo Nordisk Investigational Site
      • Sosnowiec, Poland, 41-200
        • Novo Nordisk Investigational Site
      • Szczecin-Zdunowo, Poland, 70-890
        • Novo Nordisk Investigational Site
  • South Africa
      • Worcester, South Africa, 6850
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Novo Nordisk Investigational Site
      • Cape Town, Western Cape, South Africa, 7505
        • Novo Nordisk Investigational Site
      • Cape Town, Western Cape, South Africa
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28041
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46026
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from surgery until fracture has healed
Time Frame: During a 12 month period
During a 12 month period

Secondary Outcome Measures

Outcome Measure
Investigator's assessment: fracture healed
Number of fractures healed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Actual)

October 1, 2003

Study Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

November 15, 2005

First Submitted That Met QC Criteria

November 15, 2005

First Posted (Estimate)

November 16, 2005

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1606-1365

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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