A Phase 2 interventional study of Trafermin (genetical recombination) in Periodontitis, sponsored by Kaken Pharmaceutical. Completed at 23 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2008-02-05.
Sponsored by Kaken Pharmaceutical · Phase 2, Interventional, and Treatment
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 267 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Kaken Pharmaceutical is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The patient with marginal periodontitis intend to conduct a flap operation(modified Widman) must meet the following criteria:
Exclusion Criteria:
Patients will be excluded from the study if any of the following conditions are present:
Drug: Trafermin (genetical recombination)
low dose (0.2 %)
Drug: Trafermin (genetical recombination)
medium dose (0.3 %)
Drug: Trafermin (genetical recombination)
high dose (0.4 %)
Drug: Trafermin (genetical recombination)
rate of increase in alveolar bone height
Time frame: 36 weeks after administration
clinical attachment level regained
Time frame: 36 weeks after administration
time course of increase rate in alveolar bone height
Time frame: within 36 weeks after administration
time course of clinical attachment level regained
Time frame: within 36 weeks after administration
occurrence and level of adverse reaction
Time frame: within 36 weeks after administration
serum anti-Trafermin antibody level
Time frame: within 4 weeks
serum Trafermin level
Time frame: within 24 hours
This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kaken Pharmaceutical