Radius FracturePhase 2NCT00131482
A Study to Evaluate the Safety and Effectiveness of Different Doses of Chrysalin in Adults Who Have a Broken Wrist
A Phase 2 study testing Chrysalin in people with Radius Fracture, run by Capstone Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radius Fracture
- What is being tested?
- Chrysalin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Radius Fracture
- Being tested
- Chrysalin, Placebo
- Keywords
- Chrysalin, TP508, Fracture, Wrist, Healing
- Medical subject headings
- Radius Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChrysalinDrug
Patients were treated with a single percutaneous injection of Chrysalin 3 micrograms at the fracture site at the time of surgery.
ChrysalinDrug
Patients were treated with a single percutaneous administration of Chrysalin 1 microgram at the fracture site at the time of surgery.
ChrysalinDrug
Patients were treated with a single percutaneous administration of Chrysalin 10 micrograms at the fracture site at the time of surgery.
ChrysalinDrug
Patients were treated with a single percutaneous administration of Chrysalin 30 micrograms at the fracture site at the time of surgery.
PlaceboDrug
Patients were treated with a single percutaneous administration of placebo at the fracture site at the time of surgery.
| Study group | Role | What they receive |
|---|---|---|
| 10 micrograms | Experimental | Not described Receives: Drug: Chrysalin |
| 30 micrograms | Experimental | Not described Receives: Drug: Chrysalin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| 3 micrograms | Experimental | Not described Receives: Drug: Chrysalin |
| 1 microgram | Experimental | Not described Receives: Drug: Chrysalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to removal of all rigid immobilization for fracture
Measured: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Secondary outcomes (7)
Time to clinical healing of the fracture
Measured: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Time to radiographic healing of the fracture
Measured: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Assessment of range of motion relative to unbroken wrist
Measured: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Assessment of grip strength relative to unbroken wrist
Measured: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Results of patient questionnaires
Measured: Questionnaires given Weeks 4, 6, 8, 10,12 and 26 after treatment
Incidence of treatment-emergent adverse events
Measured: Weeks 1-8, and Weeks 10, 12, 26 and 52 after treatment
Chemistry and hematology laboratory evaluations
Measured: Within 24 hours, and at Weeks 2, 4, 8, and 26 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2005 (estimated)
- Study startNov 2004
- Primary completionMar 2007
- Study completionMar 2007
Why it stopped: Treatment with Chrysalin did not demonstrate benefit compared to placebo.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radius FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capstone Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Ryaby, Ph.D., Study chair, Capstone Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131482
- Sponsor's protocol ID
- OL-ADRFX-03
- Status last verified
- Aug 2010
- First submitted
- 16 Aug 2005
- Last updated
- 24 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00131482
- Acronym / sponsor ID
- OL-ADRFX-03
- Conditions
- Radius Fracture
- Keywords
- Chrysalin, TP508, Fracture, Wrist, Healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Treatment with Chrysalin did not demonstrate benefit compared to placebo.
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Capstone TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 18 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChrysalinPatients were treated with a single percutaneous injection of Chrysalin 3 micrograms at the fracture site at the time of surgery. | Drug | 3 micrograms |
| ChrysalinPatients were treated with a single percutaneous administration of Chrysalin 1 microgram at the fracture site at the time of surgery. | Drug | 1 microgram |
| ChrysalinPatients were treated with a single percutaneous administration of Chrysalin 10 micrograms at the fracture site at the time of surgery. | Drug | 10 micrograms |
| ChrysalinPatients were treated with a single percutaneous administration of Chrysalin 30 micrograms at the fracture site at the time of surgery. | Drug | 30 micrograms |
| PlaceboPatients were treated with a single percutaneous administration of placebo at the fracture site at the time of surgery. | Drug | Placebo |
Primary outcome
Time to removal of all rigid immobilization for fracture
Time frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
7 secondary outcomes
Time to clinical healing of the fracture
Time frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Time to radiographic healing of the fracture
Time frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Assessment of range of motion relative to unbroken wrist
Time frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Assessment of grip strength relative to unbroken wrist
Time frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Results of patient questionnaires
Time frame: Questionnaires given Weeks 4, 6, 8, 10,12 and 26 after treatment
Incidence of treatment-emergent adverse events
Time frame: Weeks 1-8, and Weeks 10, 12, 26 and 52 after treatment
Chemistry and hematology laboratory evaluations
Time frame: Within 24 hours, and at Weeks 2, 4, 8, and 26 after treatment
Results and safety
The study was stopped early (reason given: Treatment with Chrysalin did not demonstrate benefit compared to placebo.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Ryaby, Ph.D. study chair
Capstone Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chrysalin in people with Radius Fracture, run by Capstone Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Treatment with Chrysalin did not demonstrate benefit compared to placebo.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to removal of all rigid immobilization for fracture (time frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2010.