NCT00131482

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

August 24, 2010

Status Verified

August 1, 2010

Enrollment Period

2.3 years

First QC Date

August 16, 2005

Last Update Submit

August 23, 2010

Conditions

Radius Fracture

Keywords

ChrysalinTP508FractureWristHealing

Outcome Measures

Primary Outcomes (1)

  • Time to removal of all rigid immobilization for fracture

    Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment

Secondary Outcomes (7)

  • Time to clinical healing of the fracture

    Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment

  • Time to radiographic healing of the fracture

    Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment

  • Assessment of range of motion relative to unbroken wrist

    Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment

  • Assessment of grip strength relative to unbroken wrist

    Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment

  • Results of patient questionnaires

    Questionnaires given Weeks 4, 6, 8, 10,12 and 26 after treatment

  • +2 more secondary outcomes

Study Arms (5)

10 micrograms

EXPERIMENTAL
Drug: Chrysalin

30 micrograms

EXPERIMENTAL
Drug: Chrysalin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

3 micrograms

EXPERIMENTAL
Drug: Chrysalin

1 microgram

EXPERIMENTAL
Drug: Chrysalin

Interventions

ChrysalinDRUG

Patients were treated with a single percutaneous injection of Chrysalin 3 micrograms at the fracture site at the time of surgery.

3 micrograms
PlaceboDRUG

Patients were treated with a single percutaneous administration of placebo at the fracture site at the time of surgery.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OrthoLogic

Tempe, Arizona, 85281, United States

Location

MeSH Terms

Conditions

Radius FracturesFractures, Bone

Interventions

rusalatide acetate

Condition Hierarchy (Ancestors)

Forearm InjuriesArm InjuriesWounds and Injuries

Study Officials

  • James Ryaby, Ph.D.

    Capstone Therapeutics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 18, 2005

Study Start

November 1, 2004

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

August 24, 2010

Record last verified: 2010-08

Locations

US(1)