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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kaken Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01015404
First received: November 16, 2009
Last updated: October 17, 2013
Last verified: October 2013

November 16, 2009
October 17, 2013
November 2009
March 2010   (final data collection date for primary outcome measure)
serum Trafermin level [ Time Frame: within 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01015404 on ClinicalTrials.gov Archive Site
  • occurrence and level of adverse reaction [ Time Frame: within 4 weeks ] [ Designated as safety issue: Yes ]
  • serum anti-Trafermin antibody level [ Time Frame: within 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)
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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Periodontitis
Drug: Trafermin
Administered to the bone defect during flap operation
Other Name: KCB-1D
  • Experimental: Experimental H
    high volume (0.6mL、0.3% Trafermin)
    Intervention: Drug: Trafermin
  • Experimental: Experimental L
    low volume (0.2mL、0.3% Trafermin)
    Intervention: Drug: Trafermin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
Not Provided
March 2010   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01015404
KCB-1D-04
No
Kaken Pharmaceutical
Kaken Pharmaceutical
Not Provided
Study Director: Chikara Ieda Kaken Pharmaceutical Co., Ltd
Kaken Pharmaceutical
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP