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A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)

This study has been completed.
Sponsor:
Information provided by:
Kaken Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01015404
First received: November 16, 2009
Last updated: June 13, 2010
Last verified: June 2010
History of Changes
  Purpose

This study aims to investigate the safety in using Trafermin (recombinant human basic fibroblast growth factor) with periodontal surgery.


Condition Intervention Phase
Periodontitis
 Drug: Trafermin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)

Further study details as provided by Kaken Pharmaceutical:

Primary Outcome Measures:
  • serum Trafermin level [ Time Frame: within 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • occurrence and level of adverse reaction [ Time Frame: within 4 weeks ] [ Designated as safety issue: Yes ]
  • serum anti-Trafermin antibody level [ Time Frame: within 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: November 2009
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental H
high volume (0.6mL、0.3% Trafermin)
 Drug: Trafermin
Administered to the bone defect during flap operation
Other Name: KCB-1D
Experimental: Experimental L
low volume (0.2mL、0.3% Trafermin)
 Drug: Trafermin
Administered to the bone defect during flap operation
Other Name: KCB-1D

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Vertical intrabony defect from radiographs at baseline
  • Age of 20 years or older

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015404

Locations
Japan
Kaken Investigational Site 5
Chiyoda-ku, Japan
Kaken Investigational Site 2
Matsudo, Japan
Kaken Investigational Site 3
Ota-ku, Japan
Kaken Investigational Site 1
Sapporo, Japan
Kaken Investigational Site 4
Shinjuku-ku, Japan
Kaken Investigational Site 6
Suita, Japan
Sponsors and Collaborators
Kaken Pharmaceutical
Investigators
Study Director: Chikara Ieda Kaken Pharmaceutical Co., Ltd
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT01015404     History of Changes
Other Study ID Numbers: KCB-1D-04
Study First Received: November 16, 2009
Last Updated: June 13, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kaken Pharmaceutical:
Trafermin
Periodontitis

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
 Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013