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

This study has been completed.
Sponsor:
Information provided by:
Kaken Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00199290
First received: September 12, 2005
Last updated: February 1, 2008
Last verified: February 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Periodontitis
 Drug: Trafermin (genetical recombination)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Further study details as provided by Kaken Pharmaceutical:

Primary Outcome Measures:
  • rate of increase in alveolar bone height [ Time Frame: 36 weeks after administration ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 267
Study Start Date: August 2005
Study Completion Date: December 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: P Drug: Trafermin (genetical recombination)
Experimental: L
low dose (0.2 %)
 Drug: Trafermin (genetical recombination)
Experimental: M
medium dose (0.3 %)
 Drug: Trafermin (genetical recombination)
Experimental: H
high dose (0.4 %)
 Drug: Trafermin (genetical recombination)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199290

Locations
Japan
Kaken Investigational Site
Nagoya, Aichi, Japan, 464-8651
Kaken Investigational Site
Matsudo, Chiba, Japan, 271-8587
Kaken Investigational Site
Kitakyusyu, Fukuoka, Japan, 803-8580
Kaken Investigational Site
Mizuho, Gifu, Japan, 501-0296
Kaken Investigational Site
Ishikari-gun, Hokkaido, Japan, 061-0293
Kaken Investigational Site
Sapporo, Hokkaido, Japan, 060-8648
Kaken Investigational Site
Morioka, Iwate, Japan, 020-8505
Kaken Investigational Site
Yokohama, Kanagawa, Japan, 230-8501
Kaken Investigational Site
Sendai, Miyagi, Japan, 980-8575
Kaken Investigational Site
Suita, Osaka, Japan, 565-0871
Kaken Investigational Site
Bunkyo-ku, Tokyo, Japan, 113-8549
Kaken Investigational Site
Chiyoda-ku, Tokyo, Japan, 101-8310
Kaken Investigational Site
Machida, Tokyo, Japan, 194-0023
Kaken Investigational Site
Sinjyuku-ku, Tokyo, Japan, 160-8582
Kaken Investigational Site
Chiba, Japan, 261-0011
Kaken Investigational Site
Fukuoka, Japan, 812-8582
Kaken Investigational Site
Fukuoka, Japan, 814-0193
Kaken Investigational Site
Hiroshima, Japan, 734-8551
Kaken Investigational Site
Kagoshima, Japan, 890-8520
Kaken Investigational Site
Nagasaki, Japan, 852-8501
Kaken Investigational Site
Niigata, Japan, 951-8122
Kaken Investigational Site
Okayama, Japan, 700-8525
Kaken Investigational Site
Tokushima, Japan, 770-8503
Sponsors and Collaborators
Kaken Pharmaceutical
Investigators
Study Director: Makoto Tamura, Ph.D Kaken Pharmaceutical Co.,Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00199290     History of Changes
Other Study ID Numbers: KCB-1D-02
Study First Received: September 12, 2005
Last Updated: February 1, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kaken Pharmaceutical:
Trafermin
Periodontitis

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 16, 2013