A Phase2 Clinical Trial of Trafermin in Patients With Marginal Periodontitis in Japan

February 1, 2008 updated by: Kaken Pharmaceutical

A Phase 2, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and the Safety of Trafermin in Patients With Marginal Periodontitis in Japan

This study is designed to evaluate the efficacy and the safety of Trafermin(recombinant human basic fibroblast growth factor: rhbFGF) in Japanese patients with marginal periodontitis, in order to verify the superiority of Trafermin to placebo, and to determine the recommended therapeutic dose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

267

Phase

  • Phase 2

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
      • Chiba, Japan, 261-0011
        • Kaken Investigational Site
      • Fukuoka, Japan, 812-8582
        • Kaken Investigational Site
      • Fukuoka, Japan, 814-0193
        • Kaken Investigational Site
      • Hiroshima, Japan, 734-8551
        • Kaken Investigational Site
      • Kagoshima, Japan, 890-8520
        • Kaken Investigational Site
      • Nagasaki, Japan, 852-8501
        • Kaken Investigational Site
      • Niigata, Japan, 951-8122
        • Kaken Investigational Site
      • Okayama, Japan, 700-8525
        • Kaken Investigational Site
      • Tokushima, Japan, 770-8503
        • Kaken Investigational Site
    • Aichi
      • Nagoya, Aichi, Japan, 464-8651
        • Kaken Investigational Site
    • Chiba
      • Matsudo, Chiba, Japan, 271-8587
        • Kaken Investigational Site
    • Fukuoka
      • Kitakyusyu, Fukuoka, Japan, 803-8580
        • Kaken Investigational Site
    • Gifu
      • Mizuho, Gifu, Japan, 501-0296
        • Kaken Investigational Site
    • Hokkaido
      • Ishikari-gun, Hokkaido, Japan, 061-0293
        • Kaken Investigational Site
      • Sapporo, Hokkaido, Japan, 060-8648
        • Kaken Investigational Site
    • Iwate
      • Morioka, Iwate, Japan, 020-8505
        • Kaken Investigational Site
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 230-8501
        • Kaken Investigational Site
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8575
        • Kaken Investigational Site
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Kaken Investigational Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8549
        • Kaken Investigational Site
      • Chiyoda-ku, Tokyo, Japan, 101-8310
        • Kaken Investigational Site
      • Machida, Tokyo, Japan, 194-0023
        • Kaken Investigational Site
      • Sinjyuku-ku, Tokyo, Japan, 160-8582
        • 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:

The patient with marginal periodontitis intend to conduct a flap operation(modified Widman) must meet the following criteria:

  • Alveolar bone defect diagnosed by radiography.
  • Mobility of teeth must be <=2 and the width of attached gingiva is suitable for GTR(guided tissue regeneration) method.
  • Males and females, >=20 years of age.

Exclusion Criteria:

Patients will be excluded from the study if any of the following conditions are present:

  • Concomitant administration of adrenal cortical steroid within 4weeks of treatment in the trial.
  • Current or previous history of gingival overgrowth by drugs.
  • Current or previous history of cancer or malignant tumour.
  • Presence of diabetes mellitus(HbA1c>=6.5%)
  • Presence of malnutrition(serum albumin<=2g/dL)
  • Pregnancy or lactation

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: P
Drug: Trafermin (genetical recombination)
Experimental: L
low dose (0.2 %)
Drug: Trafermin (genetical recombination)
Experimental: M
medium dose (0.3 %)
Drug: Trafermin (genetical recombination)
Experimental: H
high dose (0.4 %)
Drug: Trafermin (genetical recombination)

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

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical attachment level regained
Time Frame: 36 weeks after administration
36 weeks after administration
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
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
serum Trafermin level
Time Frame: within 24 hours
within 24 hours

Collaborators and Investigators

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

Sponsor

Kaken Pharmaceutical

Investigators

  • Study Director: Makoto Tamura, Ph.D, Kaken Pharmaceutical Co.,Ltd.

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, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

February 5, 2008

Last Update Submitted That Met QC Criteria

February 1, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCB-1D-02

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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