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

Primary Purpose

Periodontitis, Alveolar Bone Loss, Periodontal Attachment Loss

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Trafermin (genetical recombination)
Placebo
Sponsored by
Kaken Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

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

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

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

P

Arm Description

positive drug (0.3% Trafermin contained)

control

Outcomes

Primary Outcome Measures

rate of increase in alveolar bone height
clinical attachment level regained

Secondary Outcome Measures

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

Full Information

First Posted
August 13, 2008
Last Updated
June 14, 2012
Sponsor
Kaken Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00734708
Brief Title
Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaken Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Alveolar Bone Loss, Periodontal Attachment Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
positive drug (0.3% Trafermin contained)
Arm Title
P
Arm Type
Placebo Comparator
Arm Description
control
Intervention Type
Drug
Intervention Name(s)
Trafermin (genetical recombination)
Other Intervention Name(s)
KCB-1D
Intervention Description
Administered to the bone defect during flap operation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Control
Primary Outcome Measure Information:
Title
rate of increase in alveolar bone height
Time Frame
36 weeks after administration
Title
clinical attachment level regained
Time Frame
36 weeks after administration
Secondary Outcome Measure Information:
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
time course change of periodontal tissue inspection values
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chikara Ieda
Organizational Affiliation
Kaken Pharmaceutical Co., Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Kaken Investigational Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Kaken Investigational Site
City
Matsudo
State/Province
Chiba
Country
Japan
Facility Name
Kaken Investigational Site
City
Kitakyusyu
State/Province
Fukuoka
Country
Japan
Facility Name
Kaken Investigational Site
City
Ishikari-Tobetsu
State/Province
Hokkaido
Country
Japan
Facility Name
Kaken Investigational Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Kaken Investigational Site
City
Morioka
State/Province
Iwate
Country
Japan
Facility Name
Kaken Investigational Site
City
Machida
State/Province
Kanagawa
Country
Japan
Facility Name
Kaken Investigational Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Kaken Investigational Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Kaken Investigational Site
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Kaken Investigational Site
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kaken Investigational Site
City
Chiyoda-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kaken Investigational Site
City
Ota-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kaken Investigational Site
City
Sinjyuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kaken Investigational Site
City
Fukuoka
Country
Japan
Facility Name
Kaken Investigational Site
City
Hiroshima
Country
Japan
Facility Name
Kaken Investigational Site
City
Kagoshima
Country
Japan
Facility Name
Kaken Investigational Site
City
Nagasaki
Country
Japan
Facility Name
Kaken Investigational Site
City
Niigata
Country
Japan
Facility Name
Kaken Investigational Site
City
Okayama
Country
Japan
Facility Name
Kaken Investigational Site
City
Tokushima
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
18596969
Citation
Kitamura M, Nakashima K, Kowashi Y, Fujii T, Shimauchi H, Sasano T, Furuuchi T, Fukuda M, Noguchi T, Shibutani T, Iwayama Y, Takashiba S, Kurihara H, Ninomiya M, Kido J, Nagata T, Hamachi T, Maeda K, Hara Y, Izumi Y, Hirofuji T, Imai E, Omae M, Watanuki M, Murakami S. Periodontal tissue regeneration using fibroblast growth factor-2: randomized controlled phase II clinical trial. PLoS One. 2008 Jul 2;3(7):e2611. doi: 10.1371/journal.pone.0002611.
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Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)

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