Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131482
Status:
TERMINATED
Last Update Posted:
2010-08-24
First Post:
2005-08-16
Brief Title:
A Study to Evaluate the Safety and Effectiveness of Different Doses of Chrysalin in Adults Who Have a Broken Wrist
Sponsor:
Capstone Therapeutics
Organization:
Capstone Therapeutics
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Treatment with Chrysalin did not demonstrate benefit compared to placebo
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None