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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 16, 2005

Last Updated Date

August 23, 2010

Start Date ^ICMJE

November 2004

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Time to removal of all rigid immobilization for fracture

Change History

Complete list of historical versions of study NCT00131482 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Radius Fracture

Intervention ^ICMJE

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 Arm (s)

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

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

274

Completion Date

March 2007

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00131482

Other Study ID Numbers ^ICMJE

OL-ADRFX-03

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Denise Lamon, Director, Regulatory Affairs, Capstone Therapeutics

Study Sponsor ^ICMJE

Capstone Therapeutics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

James Ryaby, Ph.D.

Capstone Therapeutics

Information Provided By

Capstone Therapeutics

Verification Date

August 2010

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

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