A Study to Evaluate the Safety and Effectiveness of Different Doses of Chrysalin in Adults Who Have a Broken Wrist
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Radius Fracture
In brief
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.
Key facts
- Study ID
- NCT00131482
- Run by
- Capstone Therapeutics
- People needed
- 274
- Starts
- 2004-11-01
- Expected to finish
- 2007-03-01
- Last updated by the study team
- 2010-08-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- OrthoLogic — Tempe, Arizona, United States
Full record on ClinicalTrials.gov
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