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

Radius Fracture Clinical Trial

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

Clinical 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Radius Fracture
• Radius Fractures

• NCT number: NCT00131482
• Study type: Interventional
• Source: Capstone Therapeutics
• Status: Terminated
• Phase: Phase 2
• Start date: November 2004
• Completion date: March 2007