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

Tracking Information
First Submitted Date ICMJE	August 16, 2005
First Posted Date ICMJE	August 18, 2005
Last Update Posted Date	August 24, 2010
Study Start Date ICMJE	November 2004
Actual Primary Completion Date	March 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 23, 2010)	Time to removal of all rigid immobilization for fracture [ Time Frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment ]
Original Primary Outcome Measures ICMJE; (submitted: August 16, 2005)	Time to removal of all rigid immobilization for fracture
Change History	Complete list of historical versions of study NCT00131482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 23, 2010)	Time to clinical healing of the fracture [ Time Frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment ]; Time to radiographic healing of the fracture [ Time Frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment ]; Assessment of range of motion relative to unbroken wrist [ Time Frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment ]; Assessment of grip strength relative to unbroken wrist [ Time Frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment ]; Results of patient questionnaires [ Time Frame: Questionnaires given Weeks 4, 6, 8, 10,12 and 26 after treatment ]; Incidence of treatment-emergent adverse events [ Time Frame: Weeks 1-8, and Weeks 10, 12, 26 and 52 after treatment ]; Chemistry and hematology laboratory evaluations [ Time Frame: Within 24 hours, and at Weeks 2, 4, 8, and 26 after treatment ]
Original Secondary Outcome Measures ICMJE; (submitted: August 16, 2005)	Time to clinical healing; Time to radiographic healing; Assessment of range of motion relative to unbroken wrist; Assessment of grip strength relative to unbroken wrist; Results of patient questionnaires; Incidence of treatment-emergent adverse events up to 52 wks
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study to Evaluate the Safety and Effectiveness of Different Doses of Chrysalin in Adults Who Have a Broken Wrist
Official Title ICMJE	A Double-blind, Randomized, Placebo-controlled Phase 2b Study to Establish the Effective Dose Range and to Evaluate the Safety of Chrysalin in Adult Subjects With a Fractured Distal Radius
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 (protein) that is an exact copy of part of the human protein thrombin, which is a protein that occurs naturally in the body. Chrysalin can be used to mimic part of the thrombin response after injury without stimulating any of the events associated with blood clotting, and can therefore accelerate the normal process of healing.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition ICMJE	Radius Fracture
Intervention ICMJE	Drug: Chrysalin Patients were treated with a single percutaneous injection of Chrysalin 3 micrograms at the fracture site at the time of surgery.; Drug: Chrysalin Patients were treated with a single percutaneous administration of Chrysalin 1 microgram at the fracture site at the time of surgery.; Drug: Chrysalin Patients were treated with a single percutaneous administration of Chrysalin 10 micrograms at the fracture site at the time of surgery.; Drug: Chrysalin Patients were treated with a single percutaneous administration of Chrysalin 30 micrograms at the fracture site at the time of surgery.; Drug: Placebo Patients were treated with a single percutaneous administration of placebo at the fracture site at the time of surgery.
Study Arms	Experimental: 10 micrograms Intervention: Drug: Chrysalin; Experimental: 30 micrograms Intervention: Drug: Chrysalin; Placebo Comparator: Placebo Intervention: Drug: Placebo; Experimental: 3 micrograms Intervention: Drug: Chrysalin; Experimental: 1 microgram Intervention: Drug: Chrysalin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: August 23, 2010)	274
Original Enrollment ICMJE; (submitted: August 16, 2005)	500
Actual Study Completion Date	March 2007
Actual Primary Completion Date	March 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00131482
Other Study ID Numbers ICMJE	OL-ADRFX-03
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Denise Lamon, Director, Regulatory Affairs, Capstone Therapeutics
Study Sponsor ICMJE	Capstone Therapeutics
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: James Ryaby, Ph.D. Capstone Therapeutics
PRS Account	Capstone Therapeutics
Verification Date	August 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP