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

• ClinicalTrials.gov Identifier: NCT00131482
• Recruitment Status: Terminated
• First Posted: August 18, 2005
• Last Update Posted: August 24, 2010
• Sponsor: Capstone Therapeutics
• Information provided by: Capstone Therapeutics

Tracking Information

• First Submitted Date: August 16, 2005
• First Posted Date: August 18, 2005
• Last Update Posted Date: August 24, 2010
• Study Start Date: November 2004
• Actual Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (submitted: August 16, 2005): Time to removal of all rigid immobilization for fracture

Current Secondary Outcome Measures (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 (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 Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Safety and Effectiveness of Different Doses of Chrysalin in Adults Who Have a Broken Wrist
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Radius Fracture

Intervention

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: August 23, 2010): 274
• Original Enrollment (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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00131482
• Other Study ID Numbers: 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: Capstone Therapeutics
• Collaborators: Not Provided

Investigators

• Study Chair: James Ryaby, Ph.D.; Capstone Therapeutics

• PRS Account: Capstone Therapeutics
• Verification Date: August 2010