Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)

Periodontitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734708
• Other study ID #: KCB-1D-03
• Status: Completed
• Phase: Phase 3
• First received: August 13, 2008
• Last updated: June 14, 2012
• Start date: August 2008

Study information

• Verified date: June 2012
• Source: Kaken Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

This study aims to verify the effectiveness of Trafermin (recombinant human basic fibroblast growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Probing pocket depth 4mm or deeper

• Vertical intrabony defect 3 mm or deeper from radiographs at baseline

• Mobility of tooth 2 degree or less

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Periodontal Attachment Loss
• Periodontitis

Intervention

Drug:
• Trafermin (genetical recombination)
Administered to the bone defect during flap operation
• Placebo
Control

Locations

Country	Name	City	State
Japan	Kaken Investigational Site	Bunkyo-ku	Tokyo
Japan	Kaken Investigational Site	Chiyoda-ku	Tokyo
Japan	Kaken Investigational Site	Fukuoka
Japan	Kaken Investigational Site	Hiroshima
Japan	Kaken Investigational Site	Ishikari-Tobetsu	Hokkaido
Japan	Kaken Investigational Site	Kagoshima
Japan	Kaken Investigational Site	Kitakyusyu	Fukuoka
Japan	Kaken Investigational Site	Machida	Kanagawa
Japan	Kaken Investigational Site	Matsudo	Chiba
Japan	Kaken Investigational Site	Morioka	Iwate
Japan	Kaken Investigational Site	Nagasaki
Japan	Kaken Investigational Site	Nagoya	Aichi
Japan	Kaken Investigational Site	Niigata
Japan	Kaken Investigational Site	Okayama
Japan	Kaken Investigational Site	Ota-ku	Tokyo
Japan	Kaken Investigational Site	Sapporo	Hokkaido
Japan	Kaken Investigational Site	Sendai	Miyagi
Japan	Kaken Investigational Site	Sinjyuku-ku	Tokyo
Japan	Kaken Investigational Site	Suita	Osaka
Japan	Kaken Investigational Site	Tokushima
Japan	Kaken Investigational Site	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Kaken Pharmaceutical

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of increase in alveolar bone height		36 weeks after administration	No
Primary	clinical attachment level regained		36 weeks after administration	No
Secondary	time course of increase rate in alveolar bone height		within 36 weeks after administration	No
Secondary	time course of clinical attachment level regained		within 36 weeks after administration	No
Secondary	time course change of periodontal tissue inspection values		within 36 weeks after administration	No
Secondary	occurrence and level of adverse reaction		within 36 weeks after administration	Yes
Secondary	serum anti-Trafermin antibody level		within 4 weeks	Yes