NCT00199290

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 5, 2008

Status Verified

February 1, 2008

Enrollment Period

1.9 years

First QC Date

September 12, 2005

Last Update Submit

February 1, 2008

Conditions

Periodontitis

Keywords

TraferminPeriodontitis

Outcome Measures

Primary Outcomes (1)

  • rate of increase in alveolar bone height

    36 weeks after administration

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (4)

P

PLACEBO COMPARATOR
Drug: Trafermin (genetical recombination)

L

EXPERIMENTAL

low dose (0.2 %)

Drug: Trafermin (genetical recombination)

M

EXPERIMENTAL

medium dose (0.3 %)

Drug: Trafermin (genetical recombination)

H

EXPERIMENTAL

high dose (0.4 %)

Drug: Trafermin (genetical recombination)

Interventions

Trafermin (genetical recombination)DRUG
HLMP

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Kaken Investigational Site

Nagoya, Aichi-ken, 464-8651, Japan

Location

Kaken Investigational Site

Chiba, Chiba, 261-0011, Japan

Location

Kaken Investigational Site

Matsudo, Chiba, 271-8587, Japan

Location

Kaken Investigational Site

Fukuoka, Fukuoka, 812-8582, Japan

Location

Kaken Investigational Site

Fukuoka, Fukuoka, 814-0193, Japan

Location

Kaken Investigational Site

Kitakyushu, Fukuoka, 803-8580, Japan

Location

Kaken Investigational Site

Mizuho, Gifu, 501-0296, Japan

Location

Kaken Investigational Site

Hiroshima, Hiroshima, 734-8551, Japan

Location

Kaken Investigational Site

Ishikari-gun, Hokkaido, 061-0293, Japan

Location

Kaken Investigational Site

Sapporo, Hokkaido, 060-8648, Japan

Location

Kaken Investigational Site

Morioka, Iwate, 020-8505, Japan

Location

Kaken Investigational Site

Kagoshima, Kagoshima-ken, 890-8520, Japan

Location

Kaken Investigational Site

Yokohama, Kanagawa, 230-8501, Japan

Location

Kaken Investigational Site

Sendai, Miyagi, 980-8575, Japan

Location

Kaken Investigational Site

Nagasaki, Nagasaki, 852-8501, Japan

Location

Kaken Investigational Site

Niigata, Niigata, 951-8122, Japan

Location

Kaken Investigational Site

Okayama, Okayama-ken, 700-8525, Japan

Location

Kaken Investigational Site

Suita, Osaka, 565-0871, Japan

Location

Kaken Investigational Site

Tokushima, Tokushima, 770-8503, Japan

Location

Kaken Investigational Site

Bunkyo-ku, Tokyo, 113-8549, Japan

Location

Kaken Investigational Site

Chiyoda-ku, Tokyo, 101-8310, Japan

Location

Kaken Investigational Site

Machida, Tokyo, 194-0023, Japan

Location

Kaken Investigational Site

Sinjyuku-ku, Tokyo, 160-8582, Japan

Location

MeSH Terms

Conditions

Periodontitis

Interventions

trafermin

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Makoto Tamura, Ph.D

    Kaken Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

August 1, 2005

Primary Completion

July 1, 2007

Study Completion

December 1, 2007

Last Updated

February 5, 2008

Record last verified: 2008-02

Locations

JP(23)