A Phase2 Clinical Trial of Trafermin in Patients With Marginal Periodontitis in Japan
NCT ID: NCT00199290
Last Updated: 2008-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
267 participants
INTERVENTIONAL
2005-08-31
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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P
Trafermin (genetical recombination)
L
low dose (0.2 %)
Trafermin (genetical recombination)
M
medium dose (0.3 %)
Trafermin (genetical recombination)
H
high dose (0.4 %)
Trafermin (genetical recombination)
Interventions
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Trafermin (genetical recombination)
Eligibility Criteria
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Inclusion Criteria
* Alveolar bone defect diagnosed by radiography.
* Mobility of teeth must be \<=2 and the width of attached gingiva is suitable for GTR(guided tissue regeneration) method.
* Males and females, \>=20 years of age.
Exclusion Criteria
* Concomitant administration of adrenal cortical steroid within 4weeks of treatment in the trial.
* Current or previous history of gingival overgrowth by drugs.
* Current or previous history of cancer or malignant tumour.
* Presence of diabetes mellitus(HbA1c\>=6.5%)
* Presence of malnutrition(serum albumin\<=2g/dL)
* Pregnancy or lactation
20 Years
ALL
No
Sponsors
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Kaken Pharmaceutical
INDUSTRY
Principal Investigators
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Makoto Tamura, Ph.D
Role: STUDY_DIRECTOR
Kaken Pharmaceutical Co., Ltd.
Locations
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Kaken Investigational Site
Nagoya, Aichi-ken, Japan
Kaken Investigational Site
Chiba, Chiba, Japan
Kaken Investigational Site
Matsudo, Chiba, Japan
Kaken Investigational Site
Fukuoka, Fukuoka, Japan
Kaken Investigational Site
Fukuoka, Fukuoka, Japan
Kaken Investigational Site
Kitakyushu, Fukuoka, Japan
Kaken Investigational Site
Mizuho, Gifu, Japan
Kaken Investigational Site
Hiroshima, Hiroshima, Japan
Kaken Investigational Site
Ishikari-gun, Hokkaido, Japan
Kaken Investigational Site
Sapporo, Hokkaido, Japan
Kaken Investigational Site
Morioka, Iwate, Japan
Kaken Investigational Site
Kagoshima, Kagoshima-ken, Japan
Kaken Investigational Site
Yokohama, Kanagawa, Japan
Kaken Investigational Site
Sendai, Miyagi, Japan
Kaken Investigational Site
Nagasaki, Nagasaki, Japan
Kaken Investigational Site
Niigata, Niigata, Japan
Kaken Investigational Site
Okayama, Okayama-ken, Japan
Kaken Investigational Site
Suita, Osaka, Japan
Kaken Investigational Site
Tokushima, Tokushima, Japan
Kaken Investigational Site
Bunkyo-ku, Tokyo, Japan
Kaken Investigational Site
Chiyoda-ku, Tokyo, Japan
Kaken Investigational Site
Machida, Tokyo, Japan
Kaken Investigational Site
Sinjyuku-ku, Tokyo, Japan
Countries
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Other Identifiers
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KCB-1D-02
Identifier Type: -
Identifier Source: org_study_id
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