Clinical trial NCT00199290: A Phase2 Clinical Trial of Trafermin in Patients With Marginal Periodontitis in Japan
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontitis
Keywords: Trafermin
Periodontitis
Lead sponsor: Kaken Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 267
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: rate of increase in alveolar bone height
timeFrame: 36 weeks after administration
Secondary outcomes:
measure: clinical attachment level regained
timeFrame: 36 weeks after administration
measure: time course of increase rate in alveolar bone height
timeFrame: within 36 weeks after administration
measure: time course of clinical attachment level regained
timeFrame: within 36 weeks after administration
measure: occurrence and level of adverse reaction
timeFrame: within 36 weeks after administration
measure: serum anti-Trafermin antibody level
timeFrame: within 4 weeks
measure: serum Trafermin level
timeFrame: within 24 hours
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Kaken Investigational Site
state: Aichi
city: Matsudo
country: Japan
facility: Kaken Investigational Site
state: Chiba
city: Kitakyusyu
country: Japan
facility: Kaken Investigational Site
state: Fukuoka
city: Mizuho
country: Japan
facility: Kaken Investigational Site
state: Gifu
city: Ishikari-gun
country: Japan
facility: Kaken Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Kaken Investigational Site
state: Hokkaido
city: Morioka
country: Japan
facility: Kaken Investigational Site
state: Iwate
city: Yokohama
country: Japan
facility: Kaken Investigational Site
state: Kanagawa
city: Sendai
country: Japan
facility: Kaken Investigational Site
state: Miyagi
city: Suita
country: Japan
facility: Kaken Investigational Site
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Kaken Investigational Site
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Kaken Investigational Site
state: Tokyo
city: Machida
country: Japan
facility: Kaken Investigational Site
state: Tokyo
city: Sinjyuku-ku
country: Japan
facility: Kaken Investigational Site
state: Tokyo
city: Chiba
country: Japan
facility: Kaken Investigational Site
city: Fukuoka
country: Japan
facility: Kaken Investigational Site
city: Fukuoka
country: Japan
facility: Kaken Investigational Site
city: Hiroshima
country: Japan
facility: Kaken Investigational Site
city: Kagoshima
country: Japan
facility: Kaken Investigational Site
city: Nagasaki
country: Japan
facility: Kaken Investigational Site
city: Niigata
country: Japan
facility: Kaken Investigational Site
city: Okayama
country: Japan
facility: Kaken Investigational Site
city: Tokushima
country: Japan
facility: Kaken Investigational Site
Study officials:
affiliation: Kaken Pharmaceutical Co., Ltd.
name: Makoto Tamura, Ph.D
role: STUDY_DIRECTOR
References: