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

Sponsor:	Kaken Pharmaceutical
Information provided by:	Kaken Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00734708

Purpose

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.

Condition	Intervention	Phase
Periodontitis Alveolar Bone Loss Periodontal Attachment Loss	Drug: Trafermin (genetical recombination) Drug: Placebo	Phase III

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

Resource links provided by NLM:

Drug Information available for: Trafermin

U.S. FDA Resources

Further study details as provided by Kaken Pharmaceutical:

Primary Outcome Measures:

rate of increase in alveolar bone height [ Time Frame: 36 weeks after administration ] [ Designated as safety issue: No ]
clinical attachment level regained [ Time Frame: 36 weeks after administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

time course of increase rate in alveolar bone height [ Time Frame: within 36 weeks after administration ] [ Designated as safety issue: No ]
time course of clinical attachment level regained [ Time Frame: within 36 weeks after administration ] [ Designated as safety issue: No ]
time course change of periodontal tissue inspection values [ Time Frame: within 36 weeks after administration ] [ Designated as safety issue: No ]
occurrence and level of adverse reaction [ Time Frame: within 36 weeks after administration ] [ Designated as safety issue: Yes ]
serum anti-Trafermin antibody level [ Time Frame: within 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	August 2008
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A positive drug (0.3% Trafermin contained)	Drug: Trafermin (genetical recombination) Administered to the bone defect during flap operation Other Name: KCB-1D
Placebo Comparator: P control	Drug: Placebo Control

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734708

Locations

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

Sponsors and Collaborators

Kaken Pharmaceutical

Investigators

Study Director:

Chikara Ieda

Kaken Pharmaceutical Co., Ltd

More Information

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00734708 History of Changes
Other Study ID Numbers:	KCB-1D-03
Study First Received:	August 13, 2008
Last Updated:	June 13, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Alveolar Bone Loss
Periodontitis
Periodontal Attachment Loss
Bone Resorption
Bone Diseases

Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on February 09, 2012