A Study to Evaluate the Safety and Effectiveness of Different Doses of Chrysalin in Adults Who Have a Broken Wrist
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ClinicalTrials.gov Identifier: NCT00131482 |
Recruitment Status
:
Terminated
(Treatment with Chrysalin did not demonstrate benefit compared to placebo.)
First Posted
: August 18, 2005
Last Update Posted
: August 24, 2010
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Sponsor:
Capstone Therapeutics
Information provided by:
Capstone Therapeutics
Tracking Information | ||||
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First Submitted Date ICMJE | August 16, 2005 | |||
First Posted Date ICMJE | August 18, 2005 | |||
Last Update Posted Date | August 24, 2010 | |||
Study Start Date ICMJE | November 2004 | |||
Actual 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 ] | |||
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 |
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Original Secondary Outcome Measures ICMJE |
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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 Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Radius Fracture | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
274 | |||
Original Enrollment ICMJE |
500 | |||
Actual Study Completion Date | March 2007 | |||
Actual Primary Completion Date | March 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
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 | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Denise Lamon, Director, Regulatory Affairs, Capstone Therapeutics | |||
Study Sponsor ICMJE | Capstone Therapeutics | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Capstone Therapeutics | |||
Verification Date | August 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |