PeriodontitisPhase 3NCT00734708
Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)
A Phase 3 study testing Trafermin (genetical recombination) in people with Periodontitis and Alveolar Bone Loss, run by Kaken Pharmaceutical at 21 sites in Japan.
Trial summary
This study aims to verify the effectiveness of Trafermin (recombinant human basic fibroblast growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Periodontitis, Alveolar Bone Loss, Periodontal Attachment Loss
- What is being tested?
- Trafermin (genetical recombination)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 21 sitesJapan
- Study dates
- Aug 2008to Mar 2010
- Phase
- Phase 3
- 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
- Probing pocket depth 4mm or deeper
- Vertical intrabony defect 3 mm or deeper from radiographs at baseline
- Mobility of tooth 2 degree or less
Who cannot join
- Using an investigational drug within the past 24 months
- Coexisting malignant tumour or history of the same
- Coexisting diabetes (HbA1C 6.5% or more)
- Taking bisphosphonates
- Coexisting gingival overgrowth or history of the same
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Japan21 sites
Kaken Investigational Site
Bunkyo-ku, Tokyo
Kaken Investigational Site
Chiyoda-ku, Tokyo
Kaken Investigational Site
Fukuoka, Fukuoka
Kaken Investigational Site
Hiroshima, Hiroshima
Kaken Investigational Site
Ishikari-Tobetsu, Hokkaido
Kaken Investigational Site
Kagoshima, Kagoshima-ken
Kaken Investigational Site
Kitakyushu, Fukuoka
Kaken Investigational Site
Machida, Kanagawa
Kaken Investigational Site
Matsudo, Chiba
Kaken Investigational Site
Morioka, Iwate
Kaken Investigational Site
Nagasaki, Nagasaki
Kaken Investigational Site
Nagoya, Aichi-ken
Kaken Investigational Site
Niigata, Niigata
Kaken Investigational Site
Okayama, Okayama-ken
Kaken Investigational Site
Ōta-ku, Tokyo
Kaken Investigational Site
Sapporo, Hokkaido
Kaken Investigational Site
Sendai, Miyagi
Kaken Investigational Site
Sinjyuku-ku, Tokyo
Kaken Investigational Site
Suita, Osaka
Kaken Investigational Site
Tokushima, Tokushima
Kaken Investigational Site
Yokohama, Kanagawa
About this study
This study aims to verify the effectiveness of Trafermin (recombinant human basic fibroblast growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation.
- Being tested
- Trafermin (genetical recombination), Placebo
- Medical subject headings
- Periodontitis, Alveolar Bone Loss, Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trafermin (genetical recombination)Drug
Also called KCB-1D
Administered to the bone defect during flap operation
PlaceboDrug
Control
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | positive drug (0.3% Trafermin contained) Receives: Drug: Trafermin (genetical recombination) |
| P | Placebo comparator | control Receives: Drug: Placebo |
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
clinical attachment level regained
Measured: 36 weeks after administration
Secondary outcomes (5)
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
time course change of periodontal tissue inspection values
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaken Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chikara Ieda, Study director, Kaken Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734708
- Sponsor's protocol ID
- KCB-1D-03
- Status last verified
- Jun 2012
- First submitted
- 13 Aug 2008
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kitamura M, Nakashima K, Kowashi Y, Fujii T, Shimauchi H, Sasano T, Furuuchi T, Fukuda M, Noguchi T, Shibutani T, Iwayama Y, Takashiba S, Kurihara H, Ninomiya M, Kido J, Nagata T, Hamachi T, Maeda K, Hara Y, Izumi Y, Hirofuji T, Imai E, Omae M, Watanuki M, Murakami S. Periodontal tissue regeneration using fibroblast growth factor-2: randomized controlled phase II clinical trial. PLoS One. 2008 Jul 2;3(7):e2611. doi: 10.1371/journal.pone.0002611.
PubMed 18596969
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)
- ClinicalTrials.gov ID
- NCT00734708
- Acronym / sponsor ID
- KCB-1D-03
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Kaken PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Mar 2010 (actual)
- First posted
- 14 Aug 2008 (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 aims to verify the effectiveness of Trafermin (recombinant human basic fibroblast growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Trafermin (genetical recombination)positive drug (0.3% Trafermin contained) |
| P | Placebo comparator | Drug: Placebocontrol |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Probing pocket depth 4mm or deeper
- Vertical intrabony defect 3 mm or deeper from radiographs at baseline
- Mobility of tooth 2 degree or less
Key exclusion criteria (5 listed)
- Using an investigational drug within the past 24 months
- Coexisting malignant tumour or history of the same
- Coexisting diabetes (HbA1C 6.5% or more)
- Taking bisphosphonates
- Coexisting gingival overgrowth or history of the same
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)Also: KCB-1DAdministered to the bone defect during flap operation | Drug | A |
| PlaceboControl | Drug | P |
Primary outcome
rate of increase in alveolar bone height
Time frame: 36 weeks after administration
clinical attachment level regained
Time frame: 36 weeks after administration
5 secondary outcomes
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
time course change of periodontal tissue inspection values
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
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 15 Jun 2012.
- Background: PubMed 18596969Kitamura M, Nakashima K, Kowashi Y, Fujii T, Shimauchi H, Sasano T, Furuuchi T, Fukuda M, Noguchi T, Shibutani T, Iwayama Y, Takashiba S, Kurihara H, Ninomiya M, Kido J, Nagata T, Hamachi T, Maeda K, Hara Y, Izumi Y, Hirofuji T, Imai E, Omae M, Watanuki M, Murakami S. Periodontal tissue regeneration using fibroblast growth factor-2: randomized controlled phase II clinical trial. PLoS One. 2008 Jul 2;3(7):e2611. doi: 10.1371/journal.pone.0002611.
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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.
Chikara Ieda study director
Kaken Pharmaceutical Co., Ltd.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trafermin (genetical recombination) in people with Periodontitis and Alveolar Bone Loss, run by Kaken Pharmaceutical at 21 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 3 inclusion and 5 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 15 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00734708, which also lists 1 linked publication.
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 15 Jun 2012.