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A Study of rhBMP-2/CPM in Closed Fractures of the Humerus

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Little Rock, Arkansas, 72205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fractures
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Skeletally mature subjects age 18 years or older.

- Subjects with either a closed proximal humeral fracture or a diaphyseal humeral
fracture.

- Treatment plan that includes only conservative (nonoperative) therapy within 48 hours
following injury.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Shoulder dislocation at the time of injury.

- Planned procedure(s) at that would stimulate fracture union at the time of application
of the initial immobilization device.

- Fractures located in the distal third of humerus.

NCT00384852
Pfizer
Completed
A Study of rhBMP-2/CPM in Closed Fractures of the Humerus

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A Study of rhBMP-2/CPM in Closed Fractures of the Humerus
A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy in Closed Fractures of the Humerus
The primary objective of this study is to assess whether fracture union is accelerated in subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy (standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard of care alone.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Fractures
Drug: rhBMP-2/CPM
  • Experimental: A
    1.0 mg/mL rhBMP-2/CPM + SOC
    Intervention: Drug: rhBMP-2/CPM
  • Experimental: B
    2.0 mg/mL rhBMP-2/CPM + SOC
    Intervention: Drug: rhBMP-2/CPM
  • Active Comparator: C
    Buffer/CPM + SOC
    Intervention: Drug: rhBMP-2/CPM
  • D
    Standard of Care Alone (SOC)
    Intervention: Drug: rhBMP-2/CPM
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
139
February 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Skeletally mature subjects age 18 years or older.
  • Subjects with either a closed proximal humeral fracture or a diaphyseal humeral fracture.
  • Treatment plan that includes only conservative (nonoperative) therapy within 48 hours following injury.

Exclusion Criteria:

  • Shoulder dislocation at the time of injury.
  • Planned procedure(s) at that would stimulate fracture union at the time of application of the initial immobilization device.
  • Fractures located in the distal third of humerus.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Brazil,   Canada,   Finland,   France,   Germany,   Mexico,   Norway,   Romania,   Sweden,   United States
 
 
NCT00384852
3100N7-212
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Brazil, [email protected]
Principal Investigator: Trial Manager For Mexico, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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