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

Purpose

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.

Condition	Intervention	Phase
Radius Fracture	Drug: Chrysalin Drug: Placebo	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by Capstone Therapeutics:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	274
Study Start Date:	November 2004
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131482

Locations

United States, Arizona
OrthoLogic
Tempe, Arizona, United States, 85281

Sponsors and Collaborators

Capstone Therapeutics

Investigators

Study Chair:

James Ryaby, Ph.D.

Capstone Therapeutics

More Information

No publications provided

Responsible Party:	Denise Lamon, Director, Regulatory Affairs, Capstone Therapeutics
ClinicalTrials.gov Identifier:	NCT00131482 History of Changes
Other Study ID Numbers:	OL-ADRFX-03
Study First Received:	August 16, 2005
Last Updated:	August 23, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Capstone Therapeutics:

Chrysalin
TP508
Fracture
Wrist
Healing

Additional relevant MeSH terms:

Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on May 22, 2013