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

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ClinicalTrials.gov Identifier: NCT01015404
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : October 21, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Periodontitis Drug: Trafermin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : November 2009
Primary Completion Date : March 2010
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. serum Trafermin level [ Time Frame: within 4 weeks ]

Secondary Outcome Measures :
  1. occurrence and level of adverse reaction [ Time Frame: within 4 weeks ]
  2. serum anti-Trafermin antibody level [ Time Frame: within 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: October 21, 2013
Last Verified: October 2013

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