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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Periodontal Diseases
Periodontitis
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 21, 2014