A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)
NCT ID: NCT01015404
Last Updated: 2013-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
25 participants
INTERVENTIONAL
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental H
high volume (0.6mL、0.3% Trafermin)
Trafermin
Administered to the bone defect during flap operation
Experimental L
low volume (0.2mL、0.3% Trafermin)
Trafermin
Administered to the bone defect during flap operation
Interventions
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Trafermin
Administered to the bone defect during flap operation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age of 20 years or older
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Kaken Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Chikara Ieda
Role: STUDY_DIRECTOR
Kaken Pharmaceutical Co., Ltd.
Locations
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Kaken Investigational Site 5
Chiyoda-ku, , Japan
Kaken Investigational Site 2
Matsudo, , Japan
Kaken Investigational Site 3
Ōta-ku, , Japan
Kaken Investigational Site 1
Sapporo, , Japan
Kaken Investigational Site 4
Shinjuku-ku, , Japan
Kaken Investigational Site 6
Suita, , Japan
Countries
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References
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Kitamura M, Nakashima K, Kowashi Y, Fujii T, Shimauchi H, Sasano T, Furuuchi T, Fukuda M, Noguchi T, Shibutani T, Iwayama Y, Takashiba S, Kurihara H, Ninomiya M, Kido J, Nagata T, Hamachi T, Maeda K, Hara Y, Izumi Y, Hirofuji T, Imai E, Omae M, Watanuki M, Murakami S. Periodontal tissue regeneration using fibroblast growth factor-2: randomized controlled phase II clinical trial. PLoS One. 2008 Jul 2;3(7):e2611. doi: 10.1371/journal.pone.0002611.
Other Identifiers
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KCB-1D-04
Identifier Type: -
Identifier Source: org_study_id