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Clinical Trials/NCT01015404
NCT01015404CompletedPhase 3

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

Kaken Pharmaceutical6 sites in 1 country25 target enrollmentStarted: November 2009Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
25
Locations
6
Primary Endpoint
serum Trafermin level
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Experimental H

Experimental

high volume (0.6mL、0.3% Trafermin)

Intervention: Trafermin (Drug)

Experimental L

Experimental

low volume (0.2mL、0.3% Trafermin)

Intervention: Trafermin (Drug)

Outcomes

Primary Outcomes

serum Trafermin level

Time Frame: within 4 weeks

Secondary Outcomes

  • occurrence and level of adverse reaction(within 4 weeks)
  • serum anti-Trafermin antibody level(within 4 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (6)

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A Study to Assess the Safety of Using... | Clinical Trial