Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)

June 14, 2012 updated by: Kaken Pharmaceutical
This study aims to verify the effectiveness of Trafermin (recombinant human basic fibroblast growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

328

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
      • Fukuoka, Japan
        • Kaken Investigational Site
      • Hiroshima, Japan
        • Kaken Investigational Site
      • Kagoshima, Japan
        • Kaken Investigational Site
      • Nagasaki, Japan
        • Kaken Investigational Site
      • Niigata, Japan
        • Kaken Investigational Site
      • Okayama, Japan
        • Kaken Investigational Site
      • Tokushima, Japan
        • Kaken Investigational Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Kaken Investigational Site
    • Chiba
      • Matsudo, Chiba, Japan
        • Kaken Investigational Site
    • Fukuoka
      • Kitakyusyu, Fukuoka, Japan
        • Kaken Investigational Site
    • Hokkaido
      • Ishikari-Tobetsu, Hokkaido, Japan
        • Kaken Investigational Site
      • Sapporo, Hokkaido, Japan
        • Kaken Investigational Site
    • Iwate
      • Morioka, Iwate, Japan
        • Kaken Investigational Site
    • Kanagawa
      • Machida, Kanagawa, Japan
        • Kaken Investigational Site
      • Yokohama, Kanagawa, Japan
        • Kaken Investigational Site
    • Miyagi
      • Sendai, Miyagi, Japan
        • Kaken Investigational Site
    • Osaka
      • Suita, Osaka, Japan
        • Kaken Investigational Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Kaken Investigational Site
      • Chiyoda-ku, Tokyo, Japan
        • Kaken Investigational Site
      • Ota-ku, Tokyo, Japan
        • Kaken Investigational Site
      • Sinjyuku-ku, Tokyo, Japan
        • Kaken Investigational Site

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:

  • Probing pocket depth 4mm or deeper
  • Vertical intrabony defect 3 mm or deeper from radiographs at baseline
  • Mobility of tooth 2 degree or less

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
positive drug (0.3% Trafermin contained)
Drug: Trafermin (genetical recombination)
Administered to the bone defect during flap operation
Other Names:
  • KCB-1D
Placebo Comparator: P
control
Drug: Placebo
Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of increase in alveolar bone height
Time Frame: 36 weeks after administration
36 weeks after administration
clinical attachment level regained
Time Frame: 36 weeks after administration
36 weeks after administration

Secondary Outcome Measures

Outcome Measure
Time Frame
time course of increase rate in alveolar bone height
Time Frame: within 36 weeks after administration
within 36 weeks after administration
time course of clinical attachment level regained
Time Frame: within 36 weeks after administration
within 36 weeks after administration
time course change of periodontal tissue inspection values
Time Frame: within 36 weeks after administration
within 36 weeks after administration
occurrence and level of adverse reaction
Time Frame: within 36 weeks after administration
within 36 weeks after administration
serum anti-Trafermin antibody level
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

August 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

August 13, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Estimate)

June 15, 2012

Last Update Submitted That Met QC Criteria

June 14, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCB-1D-03

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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