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

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
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 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.

Overall Status Completed
Start Date August 2001
Completion Date October 2003
Primary Completion Date October 2003
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Time from surgery until fracture has healed During a 12 month period
Secondary Outcome
Measure Time Frame
Investigator's assessment: fracture healed
Number of fractures healed
Enrollment 407
Condition
Intervention

Intervention Type: Drug

Intervention Name: somatropin

Eligibility

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
Facility:
Novo Nordisk Investigational Site | Kuopio, 70211, Finland
Novo Nordisk Investigational Site | Oulu, 90029, Finland
Novo Nordisk Investigational Site | Strasbourg, 67400, France
Novo Nordisk Investigational Site | Augsburg, 86156, Germany
Novo Nordisk Investigational Site | Berlin, 13353, Germany
Novo Nordisk Investigational Site | Braunschweig, 38118, Germany
Novo Nordisk Investigational Site | Hamburg, 20246, Germany
Novo Nordisk Investigational Site | Homburg, 66421, Germany
Novo Nordisk Investigational Site | Ludwigshafen, 67071, Germany
Novo Nordisk Investigational Site | Mainz, 55131, Germany
Novo Nordisk Investigational Site | München, 81366, Germany
Novo Nordisk Investigational Site | Münster, 48149, Germany
Novo Nordisk Investigational Site | Offenbach, 63069, Germany
Novo Nordisk Investigational Site | Würzburg, D-97080, Germany
Novo Nordisk Investigational Site | Budapest, 1076, Hungary
Novo Nordisk Investigational Site | Budapest, H-1043, Hungary
Novo Nordisk Investigational Site | Budapest, H-1081, Hungary
Novo Nordisk Investigational Site | Budapest, H-1125, Hungary
Novo Nordisk Investigational Site | Gyor, 9024, Hungary
Novo Nordisk Investigational Site | Miskolc, H-3526, Hungary
Novo Nordisk Investigational Site | Veszprém, H-8200, Hungary
Novo Nordisk Investigational Site | Beer Sheva, 84101, Israel
Novo Nordisk Investigational Site | Haifa, 31096, Israel
Novo Nordisk Investigational Site | Jerusalem, 91120, Israel
Novo Nordisk Investigational Site | Kfar Save, 44281, Israel
Novo Nordisk Investigational Site | Tel-Aviv, 64239, Israel
Novo Nordisk Investigational Site | Lillestrøm, 2004, Norway
Novo Nordisk Investigational Site | Oslo, 0407, Norway
Novo Nordisk Investigational Site | Gorzów, 66-400, Poland
Novo Nordisk Investigational Site | Krakow, 31-826, Poland
Novo Nordisk Investigational Site | Piekary Slaskie, 41-940, Poland
Novo Nordisk Investigational Site | Sosnowiec, 41-200, Poland
Novo Nordisk Investigational Site | Szczecin-Zdunowo, 70-890, Poland
Novo Nordisk Investigational Site | Durban, KwaZulu-Natal, 4001, South Africa
Novo Nordisk Investigational Site | Cape Town, Western Cape, 7505, South Africa
Novo Nordisk Investigational Site | Cape Town, Western Cape, 7925, South Africa
Novo Nordisk Investigational Site | Cape Town, Western Cape, South Africa
Novo Nordisk Investigational Site | Worcester, 6850, South Africa
Novo Nordisk Investigational Site | Madrid, 28041, Spain
Novo Nordisk Investigational Site | Valencia, 46026, Spain
Location Countries

Finland

France

Germany

Hungary

Israel

Norway

Poland

South Africa

Spain

Verification Date

January 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov