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

Phase 3

Completed

• Conditions: Periodontitis
• Interventions: Drug: Trafermin

• Registration Number: NCT01015404
• Lead Sponsor: Kaken Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-18
• Primary Completion: 2010-03
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-17
• Last Update Posted: 2013-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental H	Trafermin	high volume (0.6mL、0.3% Trafermin)
Experimental L	Trafermin	low volume (0.2mL、0.3% Trafermin)

Primary Outcome Measures

Name	Time	Method
serum Trafermin level	within 4 weeks

Secondary Outcome Measures

Name	Time	Method
occurrence and level of adverse reaction	within 4 weeks
serum anti-Trafermin antibody level	within 4 weeks

Trial Locations

Locations (6)

Kaken Investigational Site 5; 🇯🇵 Chiyoda-ku, Japan

Kaken Investigational Site 2; 🇯🇵 Matsudo, Japan

Kaken Investigational Site 3; 🇯🇵 Ota-ku, Japan

Kaken Investigational Site 1; 🇯🇵 Sapporo, Japan

Kaken Investigational Site 4; 🇯🇵 Shinjuku-ku, Japan

Kaken Investigational Site 6; 🇯🇵 Suita, Japan