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

NCT00131482 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2010-08-24

No results posted yet for this study

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.

Conditions

  • Radius Fracture

Interventions

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.

Sponsors & Collaborators

  • Capstone Therapeutics

    lead INDUSTRY

Principal Investigators

  • James Ryaby, Ph.D. · Capstone Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00131482 on ClinicalTrials.gov