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

This study has been terminated.
(Treatment with Chrysalin did not demonstrate benefit compared to placebo.)
Sponsor:
Information provided by:
Capstone Therapeutics
ClinicalTrials.gov Identifier:
NCT00131482
First received: August 16, 2005
Last updated: August 23, 2010
Last verified: August 2010

August 16, 2005
August 23, 2010
November 2004
March 2007   (final data collection date for primary outcome measure)
Time to removal of all rigid immobilization for fracture [ Time Frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment ] [ Designated as safety issue: No ]
Time to removal of all rigid immobilization for fracture
Complete list of historical versions of study NCT00131482 on ClinicalTrials.gov Archive Site
  • Time to clinical healing of the fracture [ Time Frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment ] [ Designated as safety issue: No ]
  • Time to radiographic healing of the fracture [ Time Frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment ] [ Designated as safety issue: No ]
  • Assessment of range of motion relative to unbroken wrist [ Time Frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment ] [ Designated as safety issue: No ]
  • Assessment of grip strength relative to unbroken wrist [ Time Frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment ] [ Designated as safety issue: No ]
  • Results of patient questionnaires [ Time Frame: Questionnaires given Weeks 4, 6, 8, 10,12 and 26 after treatment ] [ Designated as safety issue: No ]
  • Incidence of treatment-emergent adverse events [ Time Frame: Weeks 1-8, and Weeks 10, 12, 26 and 52 after treatment ] [ Designated as safety issue: Yes ]
  • Chemistry and hematology laboratory evaluations [ Time Frame: Within 24 hours, and at Weeks 2, 4, 8, and 26 after treatment ] [ Designated as safety issue: Yes ]
  • 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
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Effectiveness of Different Doses of Chrysalin in Adults Who Have a Broken Wrist
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Radius Fracture
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
274
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00131482
OL-ADRFX-03
No
Denise Lamon, Director, Regulatory Affairs, Capstone Therapeutics
Capstone Therapeutics
Not Provided
Study Chair: James Ryaby, Ph.D. Capstone Therapeutics
Capstone Therapeutics
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP