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

Radius Fracture Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00131482
• Other study ID #: OL-ADRFX-03
• Status: Terminated
• Phase: Phase 2
• First received: August 16, 2005
• Last updated: August 23, 2010
• Start date: November 2004
• Est. completion date: March 2007

Study information

• Verified date: August 2010
• Source: Capstone Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 274
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Radius Fracture
• Radius Fractures

Intervention

Drug:
• Chrysalin
Patients were treated with a single percutaneous injection of Chrysalin 3 micrograms at the fracture site at the time of surgery.
• Chrysalin
Patients were treated with a single percutaneous administration of Chrysalin 1 microgram at the fracture site at the time of surgery.
• Chrysalin
Patients were treated with a single percutaneous administration of Chrysalin 10 micrograms at the fracture site at the time of surgery.
• Chrysalin
Patients were treated with a single percutaneous administration of Chrysalin 30 micrograms at the fracture site at the time of surgery.
• Placebo
Patients were treated with a single percutaneous administration of placebo at the fracture site at the time of surgery.

Locations

Country	Name	City	State
United States	OrthoLogic	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Capstone Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to removal of all rigid immobilization for fracture		Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment	No
Secondary	Time to clinical healing of the fracture		Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment	No
Secondary	Time to radiographic healing of the fracture		Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment	No
Secondary	Assessment of range of motion relative to unbroken wrist		Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment	No
Secondary	Assessment of grip strength relative to unbroken wrist		Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment	No
Secondary	Results of patient questionnaires		Questionnaires given Weeks 4, 6, 8, 10,12 and 26 after treatment	No
Secondary	Incidence of treatment-emergent adverse events		Weeks 1-8, and Weeks 10, 12, 26 and 52 after treatment	Yes
Secondary	Chemistry and hematology laboratory evaluations		Within 24 hours, and at Weeks 2, 4, 8, and 26 after treatment	Yes