Status:
TERMINATED
A Study to Evaluate the Safety and Effectiveness of Different Doses of Chrysalin in Adults Who Have a Broken Wrist
Lead Sponsor:
Capstone Therapeutics
Conditions:
Radius Fracture
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety of Chrysalin, also known as TP508, and to determine the effectiveness of four doses of Chrysalin for treating broken wrists in adults.
Detailed Description
There is a medical need for a product that is safe and can accelerate the rate of bone healing, leading to a reduction in immobilization time. Chrysalin, also known as TP508, is a synthetic peptide (p...
Eligibility Criteria
Inclusion
- An unstable and/or displaced fracture of the distal radius
- Fracture classified as primary intra-articular or extra-articular
- Male, or non-pregnant, non-lactating female at least 18 years old. If female of childbearing potential, must have confirmed negative pregnancy test prior to administration of study product. Must agree to use a medically approved method of birth control for 6 months.
- Need ability to understand study requirements, provide written informed consent, and comply with study protocol
- Need ability to understand and provide written authorization for use and disclosure of health information per Health Insurance Portability and Accountability Act (HIPAA)
Exclusion
- History of distal radius fracture of the affected limb 2 years prior to study enrollment
- History of uncontrolled Type I or Type II diabetes mellitus
- History or clinical evidence of any active medical disease or condition which would make the subject, in the opinion of the investigator, unsuitable for the study, or could potentially confound the results of the study
- Concurrent use of other investigational (non-Food and Drug Administration \[FDA\]-approved) agent or device
- Participation in any other clinical study within 90 days prior to treatment with the study drug
- Female subjects who are pregnant or nursing
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT00131482
Start Date
November 1 2004
End Date
March 1 2007
Last Update
August 24 2010
Active Locations (1)
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1
OrthoLogic
Tempe, Arizona, United States, 85281