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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 (Responsible Party):
Kaken Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01015404
First received: November 16, 2009
Last updated: October 17, 2013
Last verified: October 2013
  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 ]

Enrollment: 25
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
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: 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:
Responsible Party: Kaken Pharmaceutical
ClinicalTrials.gov Identifier: NCT01015404     History of Changes
Other Study ID Numbers: KCB-1D-04
Study First Received: November 16, 2009
Last Updated: October 17, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kaken Pharmaceutical:
Trafermin
Periodontitis

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

ClinicalTrials.gov processed this record on November 20, 2014