A Randomized, Single-blind, Multi-center, Phase III Clinical Trail to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy

Daewoong Pharmaceutical Co. LTD.1 site in 1 country172 target enrollmentAugust 2016

ConditionsPatients With Thyroidecomy (Scheduled)

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Patients With Thyroidecomy (Scheduled)
Sponsor: Daewoong Pharmaceutical Co. LTD.
Enrollment: 172
Locations: 1
Primary Endpoint: adhesion incidence rate following 8 weeks
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized, single-blind, multi-center, Phase III clinical trial to evaluate the efficacy and safety of adhesion barrier Mediclore versus no treatment in patients with total thyroidectomy

Registry

clinicaltrials.gov

Start Date

August 2016

End Date

March 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Daewoong Pharmaceutical Co. LTD.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent
•Male or female at least 20 years of age
•Patients without clinically significant lab
•Patients scheduled for thyroidectomy

Exclusion Criteria

•Another clinical trials within 1 month
•History of previous surgery on same position
•Anticoagulant, general steroids within a week from surgery
•Immunosuppression or autoimmune disease
•General or local infection
•Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertentsion, diabetes mellitus, coagulation deficiencies)
•Incompatible medications
•History of drug or alcohol abuse, mental disorder
•Pregnant or lactating women and fertile women who is not using proper contraceptive method
•History of esophagus diseases