A Phase2 Clinical Trial of Trafermin in Patients With Marginal Periodontitis in Japan
- Registration Number
- NCT00199290
- Lead Sponsor
- Kaken Pharmaceutical
- 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 verify the superiority of Trafermin to placebo, and to determine the recommended therapeutic dose.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 267
Inclusion Criteria
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 Criteria
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description P Trafermin (genetical recombination) - L Trafermin (genetical recombination) low dose (0.2 %) M Trafermin (genetical recombination) medium dose (0.3 %) H Trafermin (genetical recombination) high dose (0.4 %)
- Primary Outcome Measures
Name Time Method rate of increase in alveolar bone height 36 weeks after administration
- Secondary Outcome Measures
Name Time Method clinical attachment level regained 36 weeks after administration time course of increase rate in alveolar bone height within 36 weeks after administration time course of clinical attachment level regained within 36 weeks after administration occurrence and level of adverse reaction within 36 weeks after administration serum anti-Trafermin antibody level within 4 weeks serum Trafermin level within 24 hours
Trial Locations
- Locations (1)
Kaken Investigational Site
🇯🇵Tokushima, Japan