NCT00131482

A Study to Evaluate the Safety and Effectiveness of Different Doses of Chrysalin in Adults Who Have a Broken Wrist

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Capstone Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radius Fracture

Interventions

Type	Name	Description
DRUG	Chrysalin	Patients were treated with a single percutaneous injection of Chrysalin 3 micrograms at the fracture site at the time of surgery.
DRUG	Chrysalin	Patients were treated with a single percutaneous administration of Chrysalin 1 microgram at the fracture site at the time of surgery.
DRUG	Chrysalin	Patients were treated with a single percutaneous administration of Chrysalin 10 micrograms at the fracture site at the time of surgery.
DRUG	Chrysalin	Patients were treated with a single percutaneous administration of Chrysalin 30 micrograms at the fracture site at the time of surgery.
DRUG	Placebo	Patients were treated with a single percutaneous administration of placebo at the fracture site at the time of surgery.

Timeline

• Start date: 2004-11-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2005-08-18
• Last updated: 2010-08-24

Locations

1 site across 1 country: United States