PeriodontitisPhase 2NCT00199290
A Phase2 Clinical Trial of Trafermin in Patients With Marginal Periodontitis in Japan
A Phase 2 study testing Trafermin (genetical recombination) in people with Periodontitis, run by Kaken Pharmaceutical at 23 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Trafermin (genetical recombination)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 23 sitesJapan
- Study dates
- Aug 2005to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Japan23 sites
Kaken Investigational Site
Bunkyo-ku, Tokyo, 113-8549
Kaken Investigational Site
Chiba, Chiba, 261-0011
Kaken Investigational Site
Chiyoda-ku, Tokyo, 101-8310
Kaken Investigational Site
Fukuoka, Fukuoka, 812-8582
Kaken Investigational Site
Fukuoka, Fukuoka, 814-0193
Kaken Investigational Site
Hiroshima, Hiroshima, 734-8551
Kaken Investigational Site
Ishikari-gun, Hokkaido, 061-0293
Kaken Investigational Site
Kagoshima, Kagoshima-ken, 890-8520
Kaken Investigational Site
Kitakyushu, Fukuoka, 803-8580
Kaken Investigational Site
Machida, Tokyo, 194-0023
Kaken Investigational Site
Matsudo, Chiba, 271-8587
Kaken Investigational Site
Mizuho, Gifu, 501-0296
Kaken Investigational Site
Morioka, Iwate, 020-8505
Kaken Investigational Site
Nagasaki, Nagasaki, 852-8501
Kaken Investigational Site
Nagoya, Aichi-ken, 464-8651
Kaken Investigational Site
Niigata, Niigata, 951-8122
Kaken Investigational Site
Okayama, Okayama-ken, 700-8525
Kaken Investigational Site
Sapporo, Hokkaido, 060-8648
Kaken Investigational Site
Sendai, Miyagi, 980-8575
Kaken Investigational Site
Sinjyuku-ku, Tokyo, 160-8582
Kaken Investigational Site
Suita, Osaka, 565-0871
Kaken Investigational Site
Tokushima, Tokushima, 770-8503
Kaken Investigational Site
Yokohama, Kanagawa, 230-8501
About this study
Official title: A Phase 2, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and the Safety of Trafermin in Patients With Marginal Periodontitis in Japan
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.
- Conditions
- Periodontitis
- Being tested
- Trafermin (genetical recombination)
- Keywords
- Trafermin, Periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trafermin (genetical recombination)Drug
| Study group | Role | What they receive |
|---|---|---|
| P | Placebo comparator | Not described Receives: Drug: Trafermin (genetical recombination) |
| L | Experimental | low dose (0.2 %) Receives: Drug: Trafermin (genetical recombination) |
| M | Experimental | medium dose (0.3 %) Receives: Drug: Trafermin (genetical recombination) |
| H | Experimental | high dose (0.4 %) Receives: Drug: Trafermin (genetical recombination) |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of increase in alveolar bone height
Measured: 36 weeks after administration
Secondary outcomes (6)
clinical attachment level regained
Measured: 36 weeks after administration
time course of increase rate in alveolar bone height
Measured: within 36 weeks after administration
time course of clinical attachment level regained
Measured: within 36 weeks after administration
occurrence and level of adverse reaction
Measured: within 36 weeks after administration
serum anti-Trafermin antibody level
Measured: within 4 weeks
serum Trafermin level
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionJul 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaken Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Makoto Tamura, Ph.D, Study director, Kaken Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199290
- Sponsor's protocol ID
- KCB-1D-02
- Status last verified
- Feb 2008
- First submitted
- 12 Sep 2005
- Last updated
- 5 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and the Safety of Trafermin in Patients With Marginal Periodontitis in Japan
- ClinicalTrials.gov ID
- NCT00199290
- Acronym / sponsor ID
- KCB-1D-02
- Conditions
- Periodontitis
- Keywords
- Trafermin, Periodontitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Kaken PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| P | Placebo comparator | Drug: Trafermin (genetical recombination) |
| L | Experimental | Drug: Trafermin (genetical recombination)low dose (0.2 %) |
| M | Experimental | Drug: Trafermin (genetical recombination)medium dose (0.3 %) |
| H | Experimental | Drug: Trafermin (genetical recombination)high dose (0.4 %) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trafermin (genetical recombination) | Drug | H, L, M, P |
Primary outcome
rate of increase in alveolar bone height
Time frame: 36 weeks after administration
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Makoto Tamura, Ph.D study director
Kaken Pharmaceutical Co., Ltd.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trafermin (genetical recombination) in people with Periodontitis, run by Kaken Pharmaceutical at 23 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of increase in alveolar bone height (time frame: 36 weeks after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2008.