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A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)

Primary Purpose

Periodontitis

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Trafermin

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Trafermin, Periodontitis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Kaken Investigational Site 5
Kaken Investigational Site 2
Kaken Investigational Site 3
Kaken Investigational Site 1
Kaken Investigational Site 4
Kaken Investigational Site 6

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Experimental H

Experimental L

Arm Description

high volume (0.6mL、0.3% Trafermin)

low volume (0.2mL、0.3% Trafermin)

Outcomes

Primary Outcome Measures

serum Trafermin level

Secondary Outcome Measures

occurrence and level of adverse reaction

serum anti-Trafermin antibody level

Full Information

NCT ID

NCT01015404

First Posted

November 16, 2009

Last Updated

October 17, 2013

Sponsor

Kaken Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT01015404

Brief Title

A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)

Official Title

A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kaken Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis

Keywords

Trafermin, Periodontitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental H

Arm Type

Experimental

Arm Description

high volume (0.6mL、0.3% Trafermin)

Arm Title

Experimental L

Arm Type

Experimental

Arm Description

low volume (0.2mL、0.3% Trafermin)

Intervention Type

Drug

Intervention Name(s)

Trafermin

Other Intervention Name(s)

KCB-1D

Intervention Description

Administered to the bone defect during flap operation

Primary Outcome Measure Information:

Title

serum Trafermin level

Time Frame

within 4 weeks

Secondary Outcome Measure Information:

Title

occurrence and level of adverse reaction

Time Frame

within 4 weeks

Title

serum anti-Trafermin antibody level

Time Frame

within 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Vertical intrabony defect from radiographs at baseline Age of 20 years or older Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chikara Ieda

Organizational Affiliation

Kaken Pharmaceutical Co., Ltd

Official's Role

Study Director

Facility Information:

Facility Name

Kaken Investigational Site 5

City

Chiyoda-ku

Country

Japan

Facility Name

Kaken Investigational Site 2

City

Matsudo

Country

Japan

Facility Name

Kaken Investigational Site 3

City

Ota-ku

Country

Japan

Facility Name

Kaken Investigational Site 1

City

Sapporo

Country

Japan

Facility Name

Kaken Investigational Site 4

City

Shinjuku-ku

Country

Japan

Facility Name

Kaken Investigational Site 6

City

Suita

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

18596969

Citation

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.

Results Reference

result

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A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)

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