NCT01015404

Brief Summary

This study aims to investigate the safety in using Trafermin (recombinant human basic fibroblast growth factor) with periodontal surgery.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

6 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

November 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Last Updated

October 21, 2013

Status Verified

October 1, 2013

Enrollment Period

4 months

First QC Date

November 16, 2009

Last Update Submit

October 17, 2013

Conditions

Periodontitis

Keywords

TraferminPeriodontitis

Outcome Measures

Primary Outcomes (1)

  • serum Trafermin level

    within 4 weeks

Secondary Outcomes (2)

  • occurrence and level of adverse reaction

    within 4 weeks

  • serum anti-Trafermin antibody level

    within 4 weeks

Study Arms (2)

Experimental H

EXPERIMENTAL

high volume (0.6mL、0.3% Trafermin)

Drug: Trafermin

Experimental L

EXPERIMENTAL

low volume (0.2mL、0.3% Trafermin)

Drug: Trafermin

Interventions

TraferminDRUG

Administered to the bone defect during flap operation

Also known as: KCB-1D
Experimental HExperimental L

Eligibility Criteria

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

You may qualify if:

  • Vertical intrabony defect from radiographs at baseline
  • Age of 20 years or older

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 (6)

Kaken Investigational Site 5

Chiyoda-ku, Japan

Location

Kaken Investigational Site 2

Matsudo, Japan

Location

Kaken Investigational Site 3

Ōta-ku, Japan

Location

Kaken Investigational Site 1

Sapporo, Japan

Location

Kaken Investigational Site 4

Shinjuku-ku, Japan

Location

Kaken Investigational Site 6

Suita, 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: 18596969RESULT

MeSH Terms

Conditions

Periodontitis

Interventions

trafermin

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Chikara Ieda

    Kaken Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 18, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2010

Last Updated

October 21, 2013

Record last verified: 2013-10

Locations

JP(6)