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

Kaken Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Periodontitis

Treatments: Drug: Trafermin (genetical recombination)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00199290

KCB-1D-02

Details and patient eligibility

About

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.

Enrollment: 267 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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267 participants in 4 patient groups, including a placebo group

P

Placebo Comparator group

Treatment:

Drug: Trafermin (genetical recombination)

L

Experimental group

Description:

low dose (0.2 %)

Treatment:

Drug: Trafermin (genetical recombination)

M

Experimental group

Description:

medium dose (0.3 %)

Treatment:

Drug: Trafermin (genetical recombination)

H

Experimental group

Description:

high dose (0.4 %)

Treatment:

Drug: Trafermin (genetical recombination)