A Study to Evaluate the Safety and Effectiveness of Different Doses of Chrysalin in Adults Who Have a Broken Wrist

• Status: Terminated
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Capstone Therapeutics
• Treatments: Thrombin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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