Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin) - Tabular View

Tracking Information

First Received Date ^ICMJE

August 13, 2008

Last Updated Date

May 8, 2009

Start Date ^ICMJE

August 2008

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

rate of increase in alveolar bone height [ Time Frame: 36 weeks after administration ] [ Designated as safety issue: No ]
clinical attachment level regained [ Time Frame: 36 weeks after administration ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00734708 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

time course of increase rate in alveolar bone height [ Time Frame: within 36 weeks after administration ] [ Designated as safety issue: No ]
time course of clinical attachment level regained [ Time Frame: within 36 weeks after administration ] [ Designated as safety issue: No ]
time course change of periodontal tissue inspection values [ Time Frame: within 36 weeks after administration ] [ Designated as safety issue: No ]
occurrence and level of adverse reaction [ Time Frame: within 36 weeks after administration ] [ Designated as safety issue: Yes ]
serum anti-Trafermin antibody level [ Time Frame: within 4 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)

Official Title ^ICMJE

Brief Summary

This study aims to verify the effectiveness of Trafermin (recombinant human basic fibroblast growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose:  Treatment

Condition ^ICMJE

Periodontitis
Alveolar Bone Loss
Periodontal Attachment Loss

Intervention ^ICMJE

Drug: Trafermin (genetical recombination)
Administered to the bone defect during flap operation

Other Name: KCB-1D
Drug: Placebo
Control

Study Arms / Comparison Groups

A: Experimental
positive drug (0.3% Trafermin contained)

Intervention: Drug: Trafermin (genetical recombination)
P: Placebo Comparator
control

Intervention: Drug: Placebo

Publications *

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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

300

Completion Date

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Probing pocket depth 4mm or deeper
Vertical intrabony defect 3 mm or deeper from radiographs at baseline
Mobility of tooth 2 degree or less

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00734708

Responsible Party

Study ID Numbers ^ICMJE

KCB-1D-03

Study Sponsor ^ICMJE

Kaken Pharmaceutical

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Chikara Ieda

Kaken Pharmaceutical Co., Ltd

Information Provided By

Kaken Pharmaceutical

Verification Date

May 2009

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