PeriodontitisPhase 2NCT00514657
Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2
A Phase 2 study testing Trafermin (genetical recombinant of human basic Fibroblast Growth Factor) in people with Periodontitis, run by Kaken Pharmaceutical.
Trial summary
The present clinical trial clarified that basic fibroblast growth factor-2 (FGF-2) can induce regeneration of periodontal tissue lost by progression of periodontitis and evaluated the safety of such induction. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- Dec 2001to Feb 2004
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed as 2- or 3-walled vertical intrabony defect >=3 mm deep from the top of the remaining alveolar bone
- with mobility of the tooth of degree 2 or less
- with width of attached gingiva appropriate for Guided Tissue Regeneration
Who cannot join
- concomitant administration of adrenal cortical steroid within 4 wks after the surgery
- administeration of calcium antagonist during the 4 weeks preceding administration of the investigational drug
- coexisting malignant tumour or history of the same
- coexisting diabetes (HbA1C >= 6.5%)
- an extremely poor nutritional condition (serum albumin concentration <2 g/dL)
- pregnancy or lactation
About this study
Official title: Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2 (Randomised Controlled Phase II Clinical Trial)
The present clinical trial clarified that basic fibroblast growth factor-2 (FGF-2) can induce regeneration of periodontal tissue lost by progression of periodontitis and evaluated the safety of such induction.
- Conditions
- Periodontitis
- Being tested
- Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)
- 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 recombinant of human basic Fibroblast Growth Factor)Drug
| Study group | Role | What they receive |
|---|---|---|
| P | Placebo comparator | Not described Receives: Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor) |
| L | Experimental | low dose (0.03 %) Receives: Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor) |
| M | Experimental | medium dose (0.1 %) Receives: Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor) |
| H | Experimental | high dose (0.3 %) Receives: Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor) |
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 (CAL) regained
Measured: 36 weeks after administration
Secondary outcomes (3)
time course of rate of increase in alveolar bone height
Measured: within 36 weeks after administration
time course of CAL regained
Measured: within 36 weeks after administration
the other periodontal inspections (PD, BOP, GI etc.)
Measured: within 36 weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startDec 2001
- Study completionFeb 2004
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 91 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
- NCT00514657
- Sponsor's protocol ID
- KCB-1D-01
- Status last verified
- Aug 2007
- First submitted
- 9 Aug 2007
- Last updated
- 10 Aug 2007
- 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 10 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2 (Randomised Controlled Phase II Clinical Trial)
- ClinicalTrials.gov ID
- NCT00514657
- Acronym / sponsor ID
- KCB-1D-01
- Conditions
- Periodontitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Kaken PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Study completion
- Feb 2004 (actual)
- First posted
- 10 Aug 2007 (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.
The present clinical trial clarified that basic fibroblast growth factor-2 (FGF-2) can induce regeneration of periodontal tissue lost by progression of periodontitis and evaluated the safety of such induction.
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 recombinant of human basic Fibroblast Growth Factor) |
| L | Experimental | Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)low dose (0.03 %) |
| M | Experimental | Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)medium dose (0.1 %) |
| H | Experimental | Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)high dose (0.3 %) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed as 2- or 3-walled vertical intrabony defect >=3 mm deep from the top of the remaining alveolar bone
- with mobility of the tooth of degree 2 or less
- with width of attached gingiva appropriate for Guided Tissue Regeneration
Key exclusion criteria (6 listed)
- concomitant administration of adrenal cortical steroid within 4 wks after the surgery
- administeration of calcium antagonist during the 4 weeks preceding administration of the investigational drug
- coexisting malignant tumour or history of the same
- coexisting diabetes (HbA1C >= 6.5%)
- an extremely poor nutritional condition (serum albumin concentration <2 g/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 recombinant of human basic Fibroblast Growth Factor) | Drug | H, L, M, P |
Primary outcome
rate of increase in alveolar bone height
Time frame: 36 weeks after administration
clinical attachment level (CAL) regained
Time frame: 36 weeks after administration
3 secondary outcomes
time course of rate of increase in alveolar bone height
Time frame: within 36 weeks after administration
time course of CAL regained
Time frame: within 36 weeks after administration
the other periodontal inspections (PD, BOP, GI etc.)
Time frame: within 36 weeks after administration
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 10 Aug 2007.
- Derived from this study: 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.
Makoto Tamura, Ph.D study director
Kaken Pharmaceutical Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trafermin (genetical recombinant of human basic Fibroblast Growth Factor) in people with Periodontitis, run by Kaken Pharmaceutical.
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 6 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 10 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
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). 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 NCT00514657, 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 10 Aug 2007.