Trial record 2 of 16 for:
amg 785
Study of AMG 785 in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
This study has been completed.
Sponsor:
Amgen
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00907296
First received: May 21, 2009
Last updated: May 22, 2013
Last verified: May 2013
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Purpose
This is an international, multi-center, randomized, double blind, placebo controlled study of AMG 785 in skeletally mature adults with a fresh unilateral tibial diaphyseal fracture status post a definitive fracture fixation with an intramedullary (IM) nail. The primary hypothesis for this study is that AMG 785 compared with placebo is effective in reducing radiographic healing time of fresh tibial diaphyseal fractures.
| Condition | Intervention | Phase |
|---|---|---|
|
Fracture Healing |
Drug: AMG 785 210mg Drug: AMG 785 70mg Drug: AMG 785 140 mg Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multi-center, Randomized, Double Blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults With a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation With an Intramedullary Nail |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Time to radiographic healing for the AMG 785 and placebo groups [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Physical functioning as measured by change from baseline in the SF-36 PF [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Subject incidence of revision surgery [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Time to clinical healing as determined by the ability to bear weight on the fractured limb and the absence of pain at the fracture site [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 402 |
| Study Start Date: | September 2009 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AMG 785 dose group 5
Three doses of 140mg AMG 785
|
Drug: AMG 785 140 mg
140mg AMG 785, subcutaneous (under the skin) injection
|
|
Experimental: AMG 785 dose group 3
Two doses of 70mg AMG 785
|
Drug: AMG 785 70mg
70mg AMG 785, subcutaneous (under the skin) injection
|
|
Experimental: AMG 785 dose group 6
Two doses of 140mg AMG 785
|
Drug: AMG 785 140 mg
140mg AMG 785, subcutaneous (under the skin) injection
|
|
Experimental: AMG 785 dose group 8
Three doses of 210mg AMG 785
|
Drug: AMG 785 210mg
210mg AMG 785, subcutaneous (under the skin) injection
|
|
Experimental: AMG 785 dose group 7
Four doses of 210mg AMG 785
|
Drug: AMG 785 210mg
210mg AMG 785, subcutaneous (under the skin) injection
|
|
Experimental: AMG 785 dose group 1
Four doses of 70mg AMG 785
|
Drug: AMG 785 70mg
70mg AMG 785, subcutaneous (under the skin) injection
|
|
Experimental: AMG 785 dose group 2
Three doses of 70mg AMG 785
|
Drug: AMG 785 70mg
70mg AMG 785, subcutaneous (under the skin) injection
|
|
Experimental: AMG 785 dose group 4
Four doses of 140mg AMG 785
|
Drug: AMG 785 140 mg
140mg AMG 785, subcutaneous (under the skin) injection
|
|
Experimental: AMG 785 dose group 9
Two doses of 210mg AMG 785
|
Drug: AMG 785 210mg
210mg AMG 785, subcutaneous (under the skin) injection
|
|
Placebo Comparator: Placebo arm
Four doses of placebo
|
Drug: Placebo
Placebo, subcutaneous (under the skin) injection
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Skeletally mature adults, age 18 to 85 years with radiographically closed growth plates
- Fresh unilateral closed or Gustilo type I or type II open tibial fracture
- Definitive fracture fixation with reamed (closed and open fractures) or unreamed (open fractures only) intramedullary nailing
Exclusion Criteria:
- Major polytrauma or significant axial trauma
- Associated lower extremity fracture that will delay subject's ability to bear weight beyond the normal time expected for a tibial shaft fracture
- Use of bone grafts at the time of fracture fixation
- Pathological fracture or metabolic or bone disease
- History of symptomatic spinal stenosis or facial nerve paralysis
- Malignancy within the last 5 years
- Evidence of the following (currently or within the past 5 years): elevated transaminases, significantly impaired renal function, current hyper- or hypocalcaemia
- Use of agents affecting bone metabolism
- Subject refuses to use appropriate methods of contraception
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907296
Show 103 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907296
Show 103 Study Locations
Sponsors and Collaborators
Amgen
UCB Pharma
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00907296 History of Changes |
| Other Study ID Numbers: | 20062017 2008-008392-34 |
| Study First Received: | May 21, 2009 |
| Last Updated: | May 22, 2013 |
| Health Authority: | Bulgaria: Bulgarian Drug Agency Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada Denmark: Danish Medicines Agency European Union: European Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization for Medicines India: Central Drugs Standard Control Organization Italy: Ministry of Health Latvia: State Agency of Medicines Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: Romanian National Drug Agency Russia: Ministry of Health Slovakia: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Fracture Healing Tibial Diaphyseal Fracture |
Additional relevant MeSH terms:
|
Fractures, Bone Wounds and Injuries Polystyrene sulfonic acid |
Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 27, 2016