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| Sponsor: | Wyeth |
|---|---|
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00161629 |
Purpose
To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal radius fractures. The key safety variables comprising this assessment are: 1) incidence of delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence of local neurovascular events (those involving the region under study [RUS]); and 4) rate of fracture displacement. The primary objective will be met if these outcomes in the active and placebo treatment groups are at least comparable to those of the SOC control group.
| Condition | Intervention | Phase |
|---|---|---|
|
Radius Fractures |
Drug: rhBMP-2/CPM |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study |
| Official 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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2005 |
| Study Completion Date: | January 2007 |
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Other inclusion applies.
Exclusion Criteria:
Other exclusion applies.
Contacts and Locations| Finland | |
| Turku, Finland, 20520 | |
| Kuopio, Finland, 70211 | |
| Oulu, Finland, 70211 | |
| France | |
| Paris, France, 75970 | |
| Paris, France, 75651 | |
| Paris, France, 75012 | |
| Creteil, France, 94010 | |
| Study Director: | Medical Monitor | Wyeth |
| Principal Investigator: | Trial Manager | For Finland, MedInfoNord@wyeth.com |
More Information
| Study ID Numbers: | 3100N7-114 |
| Study First Received: | September 1, 2005 |
| Last Updated: | December 3, 2007 |
| ClinicalTrials.gov Identifier: | NCT00161629 History of Changes |
| Health Authority: | Finland: Ethics Committee; France: Ministry of Health |
|
Distal Radius Fractures |
|
Fractures, Bone Wounds and Injuries Forearm Injuries |
Disorders of Environmental Origin Radius Fractures Arm Injuries |