Periodontitis Clinical Trial
Official title:
A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)
Verified date | October 2013 |
Source | Kaken Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
This study aims to investigate the safety in using Trafermin (recombinant human basic fibroblast growth factor) with periodontal surgery.
Status | Completed |
Enrollment | 25 |
Est. completion date | |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
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 |
Lead Sponsor | Collaborator |
---|---|
Kaken Pharmaceutical |
Japan,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | serum Trafermin level | within 4 weeks | Yes | |
Secondary | occurrence and level of adverse reaction | within 4 weeks | Yes | |
Secondary | serum anti-Trafermin antibody level | within 4 weeks | Yes |
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