Status:
COMPLETED
A Phase2 Clinical Trial of Trafermin in Patients With Marginal Periodontitis in Japan
Lead Sponsor:
Kaken Pharmaceutical
Conditions:
Periodontitis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the efficacy and the safety of Trafermin(recombinant human basic fibroblast growth factor: rhbFGF) in Japanese patients with marginal periodontitis, in order to veri...
Eligibility Criteria
Inclusion
- The patient with marginal periodontitis intend to conduct a flap operation(modified Widman) must meet the following 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
- Patients will be excluded from the study if any of the following conditions are present:
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT00199290
Start Date
August 1 2005
End Date
December 1 2007
Last Update
February 5 2008
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Kaken Investigational Site
Nagoya, Aichi-ken, Japan, 464-8651
2
Kaken Investigational Site
Chiba, Chiba, Japan, 261-0011
3
Kaken Investigational Site
Matsudo, Chiba, Japan, 271-8587
4
Kaken Investigational Site
Fukuoka, Fukuoka, Japan, 812-8582