search
Back to results

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

Primary Purpose

Radius Fracture

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chrysalin
Chrysalin
Chrysalin
Chrysalin
Placebo
Sponsored by
Capstone Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radius Fracture focused on measuring Chrysalin, TP508, Fracture, Wrist, Healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • OrthoLogic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

10 micrograms

30 micrograms

Placebo

3 micrograms

1 microgram

Arm Description

Outcomes

Primary Outcome Measures

Time to removal of all rigid immobilization for fracture

Secondary Outcome Measures

Time to clinical healing of the fracture
Time to radiographic healing of the fracture
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
Chemistry and hematology laboratory evaluations

Full Information

First Posted
August 16, 2005
Last Updated
August 23, 2010
Sponsor
Capstone Therapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT00131482
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Terminated
Why Stopped
Treatment with Chrysalin did not demonstrate benefit compared to placebo.
Study Start Date
November 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Capstone Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fracture
Keywords
Chrysalin, TP508, Fracture, Wrist, Healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 micrograms
Arm Type
Experimental
Arm Title
30 micrograms
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
3 micrograms
Arm Type
Experimental
Arm Title
1 microgram
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Chrysalin
Intervention Description
Patients were treated with a single percutaneous injection of Chrysalin 3 micrograms at the fracture site at the time of surgery.
Intervention Type
Drug
Intervention Name(s)
Chrysalin
Intervention Description
Patients were treated with a single percutaneous administration of Chrysalin 1 microgram at the fracture site at the time of surgery.
Intervention Type
Drug
Intervention Name(s)
Chrysalin
Intervention Description
Patients were treated with a single percutaneous administration of Chrysalin 10 micrograms at the fracture site at the time of surgery.
Intervention Type
Drug
Intervention Name(s)
Chrysalin
Intervention Description
Patients were treated with a single percutaneous administration of Chrysalin 30 micrograms at the fracture site at the time of surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients were treated with a single percutaneous administration of placebo at the fracture site at the time of surgery.
Primary Outcome Measure Information:
Title
Time to removal of all rigid immobilization for fracture
Time Frame
Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Secondary Outcome Measure Information:
Title
Time to clinical healing of the fracture
Time Frame
Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Title
Time to radiographic healing of the fracture
Time Frame
Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Title
Assessment of range of motion relative to unbroken wrist
Time Frame
Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Title
Assessment of grip strength relative to unbroken wrist
Time Frame
Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Title
Results of patient questionnaires
Time Frame
Questionnaires given Weeks 4, 6, 8, 10,12 and 26 after treatment
Title
Incidence of treatment-emergent adverse events
Time Frame
Weeks 1-8, and Weeks 10, 12, 26 and 52 after treatment
Title
Chemistry and hematology laboratory evaluations
Time Frame
Within 24 hours, and at Weeks 2, 4, 8, and 26 after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Ryaby, Ph.D.
Organizational Affiliation
Capstone Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
OrthoLogic
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs