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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kaken Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00734708
First received: August 13, 2008
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Periodontitis
Alveolar Bone Loss
Periodontal Attachment Loss
Drug: Trafermin (genetical recombination)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Kaken Pharmaceutical:

Primary Outcome Measures:
  • rate of increase in alveolar bone height [ Time Frame: 36 weeks after administration ] [ Designated as safety issue: No ]
  • clinical attachment level regained [ Time Frame: 36 weeks after administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time course of increase rate in alveolar bone height [ Time Frame: within 36 weeks after administration ] [ Designated as safety issue: No ]
  • time course of clinical attachment level regained [ Time Frame: within 36 weeks after administration ] [ Designated as safety issue: No ]
  • time course change of periodontal tissue inspection values [ Time Frame: within 36 weeks after administration ] [ Designated as safety issue: No ]
  • occurrence and level of adverse reaction [ Time Frame: within 36 weeks after administration ] [ Designated as safety issue: Yes ]
  • serum anti-Trafermin antibody level [ Time Frame: within 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 328
Study Start Date: August 2008
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
positive drug (0.3% Trafermin contained)
Drug: Trafermin (genetical recombination)
Administered to the bone defect during flap operation
Other Name: KCB-1D
Placebo Comparator: P
control
Drug: Placebo
Control

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734708

Locations
Japan
Kaken Investigational Site
Nagoya, Aichi, Japan
Kaken Investigational Site
Matsudo, Chiba, Japan
Kaken Investigational Site
Kitakyusyu, Fukuoka, Japan
Kaken Investigational Site
Ishikari-Tobetsu, Hokkaido, Japan
Kaken Investigational Site
Sapporo, Hokkaido, Japan
Kaken Investigational Site
Morioka, Iwate, Japan
Kaken Investigational Site
Machida, Kanagawa, Japan
Kaken Investigational Site
Yokohama, Kanagawa, Japan
Kaken Investigational Site
Sendai, Miyagi, Japan
Kaken Investigational Site
Suita, Osaka, Japan
Kaken Investigational Site
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
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
Sponsors and Collaborators
Kaken Pharmaceutical
Investigators
Study Director: Chikara Ieda Kaken Pharmaceutical Co., Ltd
  More Information

Publications:
Responsible Party: Kaken Pharmaceutical
ClinicalTrials.gov Identifier: NCT00734708     History of Changes
Other Study ID Numbers: KCB-1D-03
Study First Received: August 13, 2008
Last Updated: June 14, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Periodontitis
Alveolar Bone Loss
Periodontal Attachment Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy

ClinicalTrials.gov processed this record on September 16, 2014