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

Phase 2CompletedNCT00199290

Kaken Pharmaceutical267 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

267

Conditions

Periodontitis

Interventions

Trafermin (genetical recombination)DRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (23)

Kaken Investigational Site

Nagoya, Aichi-ken, Japan

Outcomes

Primary Outcomes

rate of increase in alveolar bone height

Time frame: 36 weeks after administration

Secondary Outcomes

clinical attachment level regained

Time frame: 36 weeks after administration

time course of increase rate in alveolar bone height

Time frame: within 36 weeks after administration

time course of clinical attachment level regained

Time frame: within 36 weeks after administration

occurrence and level of adverse reaction

Time frame: within 36 weeks after administration

serum anti-Trafermin antibody level

Time frame: within 4 weeks

serum Trafermin level

Time frame: within 24 hours

Data from ClinicalTrials.gov

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