NCT00734708

Brief Summary

This study aims to verify the effectiveness of Trafermin (recombinant human basic fibroblast growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
328

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

21 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, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Last Updated

June 15, 2012

Status Verified

June 1, 2012

Enrollment Period

1.6 years

First QC Date

August 13, 2008

Last Update Submit

June 14, 2012

Conditions

PeriodontitisAlveolar Bone LossPeriodontal Attachment Loss

Outcome Measures

Primary Outcomes (2)

  • rate of increase in alveolar bone height

    36 weeks after administration

  • clinical attachment level regained

    36 weeks after administration

Secondary Outcomes (5)

  • 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

  • time course change of periodontal tissue inspection values

    within 36 weeks after administration

  • occurrence and level of adverse reaction

    within 36 weeks after administration

  • serum anti-Trafermin antibody level

    within 4 weeks

Study Arms (2)

A

EXPERIMENTAL

positive drug (0.3% Trafermin contained)

Drug: Trafermin (genetical recombination)

P

PLACEBO COMPARATOR

control

Drug: Placebo

Interventions

Trafermin (genetical recombination)DRUG

Administered to the bone defect during flap operation

Also known as: KCB-1D
A
PlaceboDRUG

Control

P

Eligibility Criteria

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

You may qualify if:

  • Probing pocket depth 4mm or deeper
  • Vertical intrabony defect 3 mm or deeper from radiographs at baseline
  • Mobility of tooth 2 degree or less

You may not qualify if:

  • Using an investigational drug within the past 24 months
  • Coexisting malignant tumour or history of the same
  • Coexisting diabetes (HbA1C 6.5% or more)
  • Taking bisphosphonates
  • Coexisting gingival overgrowth or history of the same

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Kaken Investigational Site

Nagoya, Aichi-ken, Japan

Location

Kaken Investigational Site

Matsudo, Chiba, Japan

Location

Kaken Investigational Site

Fukuoka, Fukuoka, Japan

Location

Kaken Investigational Site

Kitakyushu, Fukuoka, Japan

Location

Kaken Investigational Site

Hiroshima, Hiroshima, Japan

Location

Kaken Investigational Site

Ishikari-Tobetsu, Hokkaido, Japan

Location

Kaken Investigational Site

Sapporo, Hokkaido, Japan

Location

Kaken Investigational Site

Morioka, Iwate, Japan

Location

Kaken Investigational Site

Kagoshima, Kagoshima-ken, Japan

Location

Kaken Investigational Site

Machida, Kanagawa, Japan

Location

Kaken Investigational Site

Yokohama, Kanagawa, Japan

Location

Kaken Investigational Site

Sendai, Miyagi, Japan

Location

Kaken Investigational Site

Nagasaki, Nagasaki, Japan

Location

Kaken Investigational Site

Niigata, Niigata, Japan

Location

Kaken Investigational Site

Okayama, Okayama-ken, Japan

Location

Kaken Investigational Site

Suita, Osaka, Japan

Location

Kaken Investigational Site

Tokushima, Tokushima, Japan

Location

Kaken Investigational Site

Bunkyo-ku, Tokyo, Japan

Location

Kaken Investigational Site

Chiyoda-ku, Tokyo, Japan

Location

Kaken Investigational Site

Ōta-ku, Tokyo, Japan

Location

Kaken Investigational Site

Sinjyuku-ku, Tokyo, Japan

Location

Related Publications (1)

  • Kitamura M, Nakashima K, Kowashi Y, Fujii T, Shimauchi H, Sasano T, Furuuchi T, Fukuda M, Noguchi T, Shibutani T, Iwayama Y, Takashiba S, Kurihara H, Ninomiya M, Kido J, Nagata T, Hamachi T, Maeda K, Hara Y, Izumi Y, Hirofuji T, Imai E, Omae M, Watanuki M, Murakami S. Periodontal tissue regeneration using fibroblast growth factor-2: randomized controlled phase II clinical trial. PLoS One. 2008 Jul 2;3(7):e2611. doi: 10.1371/journal.pone.0002611.

    PMID: 18596969BACKGROUND

MeSH Terms

Conditions

PeriodontitisAlveolar Bone LossPeriodontal Attachment Loss

Interventions

trafermin

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal Atrophy

Study Officials

  • Chikara Ieda

    Kaken Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 14, 2008

Study Start

August 1, 2008

Primary Completion

March 1, 2010

Last Updated

June 15, 2012

Record last verified: 2012-06

Locations

JP(21)