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

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Trafermin (genetical recombination)
Sponsored by
Kaken Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Trafermin, Periodontitis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

P

L

M

H

Arm Description

low dose (0.2 %)

medium dose (0.3 %)

high dose (0.4 %)

Outcomes

Primary Outcome Measures

rate of increase in alveolar bone height

Secondary Outcome Measures

clinical attachment level regained
time course of increase rate in alveolar bone height
time course of clinical attachment level regained
occurrence and level of adverse reaction
serum anti-Trafermin antibody level
serum Trafermin level

Full Information

First Posted
September 12, 2005
Last Updated
February 1, 2008
Sponsor
Kaken Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00199290
Brief Title
A Phase2 Clinical Trial of Trafermin in Patients With Marginal Periodontitis in Japan
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kaken Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Trafermin, Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P
Arm Type
Placebo Comparator
Arm Title
L
Arm Type
Experimental
Arm Description
low dose (0.2 %)
Arm Title
M
Arm Type
Experimental
Arm Description
medium dose (0.3 %)
Arm Title
H
Arm Type
Experimental
Arm Description
high dose (0.4 %)
Intervention Type
Drug
Intervention Name(s)
Trafermin (genetical recombination)
Primary Outcome Measure Information:
Title
rate of increase in alveolar bone height
Time Frame
36 weeks after administration
Secondary Outcome Measure Information:
Title
clinical attachment level regained
Time Frame
36 weeks after administration
Title
time course of increase rate in alveolar bone height
Time Frame
within 36 weeks after administration
Title
time course of clinical attachment level regained
Time Frame
within 36 weeks after administration
Title
occurrence and level of adverse reaction
Time Frame
within 36 weeks after administration
Title
serum anti-Trafermin antibody level
Time Frame
within 4 weeks
Title
serum Trafermin level
Time Frame
within 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Makoto Tamura, Ph.D
Organizational Affiliation
Kaken Pharmaceutical Co.,Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Kaken Investigational Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8651
Country
Japan
Facility Name
Kaken Investigational Site
City
Matsudo
State/Province
Chiba
ZIP/Postal Code
271-8587
Country
Japan
Facility Name
Kaken Investigational Site
City
Kitakyusyu
State/Province
Fukuoka
ZIP/Postal Code
803-8580
Country
Japan
Facility Name
Kaken Investigational Site
City
Mizuho
State/Province
Gifu
ZIP/Postal Code
501-0296
Country
Japan
Facility Name
Kaken Investigational Site
City
Ishikari-gun
State/Province
Hokkaido
ZIP/Postal Code
061-0293
Country
Japan
Facility Name
Kaken Investigational Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Kaken Investigational Site
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Kaken Investigational Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
230-8501
Country
Japan
Facility Name
Kaken Investigational Site
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8575
Country
Japan
Facility Name
Kaken Investigational Site
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Kaken Investigational Site
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8549
Country
Japan
Facility Name
Kaken Investigational Site
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8310
Country
Japan
Facility Name
Kaken Investigational Site
City
Machida
State/Province
Tokyo
ZIP/Postal Code
194-0023
Country
Japan
Facility Name
Kaken Investigational Site
City
Sinjyuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Kaken Investigational Site
City
Chiba
ZIP/Postal Code
261-0011
Country
Japan
Facility Name
Kaken Investigational Site
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Kaken Investigational Site
City
Fukuoka
ZIP/Postal Code
814-0193
Country
Japan
Facility Name
Kaken Investigational Site
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Kaken Investigational Site
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Kaken Investigational Site
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Kaken Investigational Site
City
Niigata
ZIP/Postal Code
951-8122
Country
Japan
Facility Name
Kaken Investigational Site
City
Okayama
ZIP/Postal Code
700-8525
Country
Japan
Facility Name
Kaken Investigational Site
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan

12. IPD Sharing Statement

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

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