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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: Trafermin (genetical recombination)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: P<br> | Drug: Trafermin (genetical recombination)<br> <br> |
| Experimental: L<br>low dose (0.2 %) | Drug: Trafermin (genetical recombination)<br> <br> |
| Experimental: M<br>medium dose (0.3 %) | Drug: Trafermin (genetical recombination)<br> <br> |
| Experimental: H<br>high dose (0.4 %) | Drug: Trafermin (genetical recombination)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of increase in alveolar bone height |  | 36 weeks after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical attachment level regained |  | 36 weeks after administration | 
| time course of increase rate in alveolar bone height |  | within 36 weeks after administration | 
| time course of clinical attachment level regained |  | within 36 weeks after administration | 
| occurrence and level of adverse reaction |  | within 36 weeks after administration | 
| serum anti-Trafermin antibody level |  | within 4 weeks | 
| serum Trafermin level |  | within 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trafermin, Periodontitis