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

Sponsor
Kaken Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT00734708
Collaborator
(none)
328
Enrollment
21
Locations
2
Arms
15.6
Patients Per Site

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Trafermin (genetical recombination)
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
328 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Mar 1, 2010

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. rate of increase in alveolar bone height [36 weeks after administration]

    2. clinical attachment level regained [36 weeks after administration]

    Secondary Outcome Measures

    1. time course of increase rate in alveolar bone height [within 36 weeks after administration]

    2. time course of clinical attachment level regained [within 36 weeks after administration]

    3. time course change of periodontal tissue inspection values [within 36 weeks after administration]

    4. occurrence and level of adverse reaction [within 36 weeks after administration]

    5. serum anti-Trafermin antibody level [within 4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaken Investigational Site Nagoya Aichi Japan
    2 Kaken Investigational Site Matsudo Chiba Japan
    3 Kaken Investigational Site Kitakyusyu Fukuoka Japan
    4 Kaken Investigational Site Ishikari-Tobetsu Hokkaido Japan
    5 Kaken Investigational Site Sapporo Hokkaido Japan
    6 Kaken Investigational Site Morioka Iwate Japan
    7 Kaken Investigational Site Machida Kanagawa Japan
    8 Kaken Investigational Site Yokohama Kanagawa Japan
    9 Kaken Investigational Site Sendai Miyagi Japan
    10 Kaken Investigational Site Suita Osaka Japan
    11 Kaken Investigational Site Bunkyo-ku Tokyo Japan
    12 Kaken Investigational Site Chiyoda-ku Tokyo Japan
    13 Kaken Investigational Site Ota-ku Tokyo Japan
    14 Kaken Investigational Site Sinjyuku-ku Tokyo Japan
    15 Kaken Investigational Site Fukuoka Japan
    16 Kaken Investigational Site Hiroshima Japan
    17 Kaken Investigational Site Kagoshima Japan
    18 Kaken Investigational Site Nagasaki Japan
    19 Kaken Investigational Site Niigata Japan
    20 Kaken Investigational Site Okayama Japan
    21 Kaken Investigational Site Tokushima Japan

    Sponsors and Collaborators

    • Kaken Pharmaceutical

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kaken Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT00734708
    Other Study ID Numbers:
    • KCB-1D-03
    First Posted:
    Aug 14, 2008
    Last Update Posted:
    Jun 15, 2012
    Last Verified:
    Jun 1, 2012
    Additional relevant MeSH terms:
    Alveolar Bone Loss
    Periodontitis
    Periodontal Attachment Loss

    Study Results

    No Results Posted as of Jun 15, 2012