|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00161629 |
|
Date of registration:
|
01/09/2005 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures
|
|
Scientific title:
|
A Phase 1 Dose-Escalating, Double-Blind, Placebo-Controlled, Multicenter, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy for Closed Distal Radius Fractures |
|
Date of first enrolment:
|
September 2005 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00161629 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
Finland
|
France
| | | | | | |
|
Contacts
|
|
Name:
|
Trial Manager |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
For Finland, MedInfoNord@wyeth.com |
|
|
Name:
|
Medical Monitor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Wyeth is now a wholly owned subsidiary of Pfizer |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Adults aged 50 to 80 years of age; alert and oriented to person, place, and time.
- Acute, closed distal radius fractures (within 4 cm of the tip of the radial styloid
process), classified according to AO/ASIF as either A2 or A3 (extra-articular) or C1
or C2 (intra-articular) fractures.
- Closed fracture reduction and definitive fracture fixation performed within 7 days
after injury by means of external skeletal and/or percutaneous pin fixation. Note:
fractures that are initially treated by closed reduction and casting, then converted
to external or percutaneous pin fixation for definitive fracture fixation within 7
days after injury are eligible for the study.
Other inclusion applies.
Exclusion Criteria:
- Other fractures of the ipsilateral upper extremity (except for ulnar styloid
fractures) or the contralateral upper extremity (except for previously healed
fractures without residual functional deficit).
- Fracture fixation by other means (eg, plate and screw fixation).
- Planned treatment for the fracture includes any procedure to promote fracture healing
(eg, open reduction internal fixation, bone grafting, non-invasive modalities such as
ultrasound, electrical stimulation, etc). Note: After 12 weeks have elapsed since
administration of the treatment assignment, unanticipated procedures to promote
fracture healing are permitted as clinically indicated.
Other exclusion applies.
Age minimum:
50 Years
Age maximum:
80 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Radius Fractures
|
|
Intervention(s)
|
|
Drug: rhBMP-2/CPM
|
|
Primary Outcome(s)
|
|
Determine the safety of administering rhBMP-2/CPM to subjects with distal radius fractures that require surgical fixation.
|
|
Secondary Outcome(s)
|
|
Feasibility of the test article injection procedure and localization of the test article relative to the distal radius fracture site.
|
|
Secondary ID(s)
|
|
3100N7-114
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|