A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)

October 17, 2013 updated by: Kaken Pharmaceutical
This study aims to investigate the safety in using Trafermin (recombinant human basic fibroblast growth factor) with periodontal surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiyoda-ku, Japan
        • Kaken Investigational Site 5
      • Matsudo, Japan
        • Kaken Investigational Site 2
      • Ota-ku, Japan
        • Kaken Investigational Site 3
      • Sapporo, Japan
        • Kaken Investigational Site 1
      • Shinjuku-ku, Japan
        • Kaken Investigational Site 4
      • Suita, Japan
        • Kaken Investigational Site 6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Vertical intrabony defect from radiographs at baseline
  • Age of 20 years or older

Exclusion Criteria:

  • Using an investigational drug within the past 24 months
  • Coexisting malignant tumour or history of the same
  • Coexisting diabetes (HbA1C 6.5% or more)
  • Taking bisphosphonates
  • Coexisting gingival overgrowth or history of the same

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental H
high volume (0.6mL、0.3% Trafermin)
Drug: Trafermin
Administered to the bone defect during flap operation
Other Names:
  • KCB-1D
Experimental: Experimental L
low volume (0.2mL、0.3% Trafermin)
Drug: Trafermin
Administered to the bone defect during flap operation
Other Names:
  • KCB-1D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum Trafermin level
Time Frame: within 4 weeks
within 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
serum anti-Trafermin antibody level
Time Frame: within 4 weeks
within 4 weeks
occurrence and level of adverse reaction
Time Frame: within 4 weeks
within 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaken Pharmaceutical

Investigators

  • Study Director: Chikara Ieda, Kaken Pharmaceutical Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

November 16, 2009

First Posted (Estimate)

November 18, 2009

Study Record Updates

Last Update Posted (Estimate)

October 21, 2013

Last Update Submitted That Met QC Criteria

October 17, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCB-1D-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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