PeriodontitisPhase 3NCT01015404
A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)
A Phase 3 study testing Trafermin in people with Periodontitis, run by Kaken Pharmaceutical at 6 sites in Japan.
Trial summary
This study aims to investigate the safety in using Trafermin (recombinant human basic fibroblast growth factor) with periodontal surgery. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 6 sitesJapan
- Study dates
- Nov 2009to 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
- Vertical intrabony defect from radiographs at baseline
- Age of 20 years or older
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
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Kaken Investigational Site 5
Chiyoda-ku
Kaken Investigational Site 2
Matsudo
Kaken Investigational Site 3
Ōta-ku
Kaken Investigational Site 1
Sapporo
Kaken Investigational Site 4
Shinjuku-ku
Kaken Investigational Site 6
Suita
About this study
This study aims to investigate the safety in using Trafermin (recombinant human basic fibroblast growth factor) with periodontal surgery.
- Conditions
- Periodontitis
- Being tested
- Trafermin
- 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.
TraferminDrug
Also called KCB-1D
Administered to the bone defect during flap operation
| Study group | Role | What they receive |
|---|---|---|
| Experimental H | Experimental | high volume (0.6mL、0.3% Trafermin) Receives: Drug: Trafermin |
| Experimental L | Experimental | low volume (0.2mL、0.3% Trafermin) Receives: Drug: Trafermin |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum Trafermin level
Measured: within 4 weeks
Secondary outcomes (2)
occurrence and level of adverse reaction
Measured: within 4 weeks
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 posted18 Nov 2009 (estimated)
- Study startNov 2009
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT01015404
- Sponsor's protocol ID
- KCB-1D-04
- Status last verified
- Oct 2013
- First submitted
- 16 Nov 2009
- Last updated
- 21 Oct 2013
- 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 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)
- ClinicalTrials.gov ID
- NCT01015404
- Acronym / sponsor ID
- KCB-1D-04
- Conditions
- Periodontitis
- Keywords
- Trafermin, Periodontitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Kaken PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (actual)
- First posted
- 18 Nov 2009 (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 investigate the safety in using Trafermin (recombinant human basic fibroblast growth factor) with periodontal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental H | Experimental | Drug: Traferminhigh volume (0.6mL、0.3% Trafermin) |
| Experimental L | Experimental | Drug: Traferminlow volume (0.2mL、0.3% Trafermin) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Vertical intrabony defect from radiographs at baseline
- Age of 20 years or older
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 |
|---|---|---|
| TraferminAlso: KCB-1DAdministered to the bone defect during flap operation | Drug | Experimental H, Experimental L |
Primary outcome
serum Trafermin level
Time frame: within 4 weeks
2 secondary outcomes
occurrence and level of adverse reaction
Time frame: within 4 weeks
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 21 Oct 2013.
- Results publication: 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.
6 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 in people with Periodontitis, run by Kaken Pharmaceutical at 6 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 2 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 21 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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?
serum Trafermin level (time frame: within 4 weeks). 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 NCT01015404, 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 21 Oct 2013.