Clinical trial NCT00131482: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Radius Fracture
Keywords: Chrysalin
TP508
Fracture
Wrist
Healing
Lead sponsor: Capstone Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-08-18
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to removal of all rigid immobilization for fracture
timeFrame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Secondary outcomes:
measure: Time to clinical healing of the fracture
timeFrame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
measure: Time to radiographic healing of the fracture
timeFrame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
measure: Assessment of range of motion relative to unbroken wrist
timeFrame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
measure: Assessment of grip strength relative to unbroken wrist
timeFrame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
measure: Results of patient questionnaires
timeFrame: Questionnaires given Weeks 4, 6, 8, 10,12 and 26 after treatment
measure: Incidence of treatment-emergent adverse events
timeFrame: Weeks 1-8, and Weeks 10, 12, 26 and 52 after treatment
measure: Chemistry and hematology laboratory evaluations
timeFrame: Within 24 hours, and at Weeks 2, 4, 8, and 26 after treatment
Other outcomes:
Locations:
city: Tempe
country: United States
facility: OrthoLogic
state: Arizona
Study officials:
affiliation: Capstone Therapeutics
name: James Ryaby, Ph.D.
role: STUDY_CHAIR
References: