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Completed

NCT Number: NCT01015404

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

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

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kaken Investigational Site 5, Chiyoda-ku, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trafermin

Drug

Administered to the bone defect during flap operation

Other names: KCB-1D

Primary outcomes

  1. serum Trafermin level

    Time frame: within 4 weeks

Secondary outcomes

  1. occurrence and level of adverse reaction

    Time frame: within 4 weeks

  2. serum anti-Trafermin antibody level

    Time frame: within 4 weeks

Sponsors and collaborators

Lead sponsor

Kaken Pharmaceutical

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
First posted
Nov 18, 2009
Registry last updated
Oct 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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