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

K

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

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)

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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