A Phase2 Clinical Trial of Trafermin in Patients With Marginal Periodontitis in Japan

Periodontitis Clinical Trial

Official title:

A Phase 2, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and the Safety of Trafermin in Patients With Marginal Periodontitis in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199290
• Other study ID #: KCB-1D-02
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: February 1, 2008
• Start date: August 2005
• Est. completion date: December 2007

Study information

• Verified date: February 2008
• 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 is designed to evaluate the efficacy and the safety of Trafermin(recombinant human basic fibroblast growth factor: rhbFGF) in Japanese patients with marginal periodontitis, in order to verify the superiority of Trafermin to placebo, and to determine the recommended therapeutic dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: December 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

The patient with marginal periodontitis intend to conduct a flap operation(modified Widman) must meet the following criteria:

• Alveolar bone defect diagnosed by radiography.

• Mobility of teeth must be <=2 and the width of attached gingiva is suitable for GTR(guided tissue regeneration) method.

• Males and females, >=20 years of age.

Exclusion Criteria:

Patients will be excluded from the study if any of the following conditions are present:

• Concomitant administration of adrenal cortical steroid within 4weeks of treatment in the trial.

• Current or previous history of gingival overgrowth by drugs.

• Current or previous history of cancer or malignant tumour.

• Presence of diabetes mellitus(HbA1c>=6.5%)

• Presence of malnutrition(serum albumin<=2g/dL)

• Pregnancy or lactation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontitis

Intervention

Drug:
• Trafermin (genetical recombination)

Locations

Country	Name	City	State
Japan	Kaken Investigational Site	Bunkyo-ku	Tokyo
Japan	Kaken Investigational Site	Chiba
Japan	Kaken Investigational Site	Chiyoda-ku	Tokyo
Japan	Kaken Investigational Site	Fukuoka
Japan	Kaken Investigational Site	Fukuoka
Japan	Kaken Investigational Site	Hiroshima
Japan	Kaken Investigational Site	Ishikari-gun	Hokkaido
Japan	Kaken Investigational Site	Kagoshima
Japan	Kaken Investigational Site	Kitakyusyu	Fukuoka
Japan	Kaken Investigational Site	Machida	Tokyo
Japan	Kaken Investigational Site	Matsudo	Chiba
Japan	Kaken Investigational Site	Mizuho	Gifu
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	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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of increase in alveolar bone height		36 weeks after administration
Secondary	clinical attachment level regained		36 weeks after administration
Secondary	time course of increase rate in alveolar bone height		within 36 weeks after administration
Secondary	time course of clinical attachment level regained		within 36 weeks after administration
Secondary	occurrence and level of adverse reaction		within 36 weeks after administration
Secondary	serum anti-Trafermin antibody level		within 4 weeks
Secondary	serum Trafermin level		within 24 hours