Tympanic Membrane PerforationPhase 3NCT02550314
A Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18
A Phase 3 study testing fiblast,gelatin sponge,fibrin glue in people with Tympanic Membrane Perforation, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan.
Trial summary
To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- fiblast,gelatin sponge,fibrin glue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jul 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed concent obtained
- At the time of obtaining informed consent, Ages ranged from over 20 to 80
- At the time of obtaining informed consent, only those with tympanic membrane perforation in 1 ear (not both) for over 6 months (perforation in both ears is excluded)
Who cannot join
- TMP caused by burn or radiation therapy
- In patients with chronic otitis media with ear drum perforation, tympanic cavity are not dry
- Inflammatory,infection or otorrhea in patient's eardrum,earcanal,middle ear and tympanic cavity
- No invasion of epithelial and no cholesteatoma in tympanic cavity or around perforated edge
- History of tympanoplasty
- A Part of the eardrum adhered to tympanic cavity
Show all 17Show fewer
- By temporal bone CT, soft tissue shadow in mastoid antrum or tympanic (using a CT image of less than 12 wks before patients registration)
- Abnormality in the chain and ear ossicles
- Air-bone gap difference more than 25dB by patch hearing test
- Unable to see whole edge of TMP due to narrow external auditory canal
- Unable to wash out Ear drops during the treatment period
- Presenting with uncontrolled diabetes (NGSP HbA1c 6.9% and more)
- Presenting with autoimmune disease
- History of malignancy within 3 years prior to obtained informed concent
- Administration of immunosuppressive agent or anti-cancer-agent
- History of Allergic reaction to local anesthetic(Xylocaine), bFGF(Fiblast spray), fibrin glue(Beriplast P Combi set, etc.), gelatin sponge formulation(spongel) and others
- Though out the period from screening to treatment, patient who is unable to wash out "Thrombolytic agent", "Anticoagulant", "Anti-platelet agent", "Procoagulant agent", "anti-line solvent"and"aprotinin formulation"
About this study
Official title: A Phase III Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18-multicenter,Investigator Initiated Clinical Trial
To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18.
- Conditions
- Tympanic Membrane Perforation
- Being tested
- fiblast,gelatin sponge,fibrin glue
- Medical subject headings
- Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiblast,gelatin sponge,fibrin glueDrug
| Study group | Role | What they receive |
|---|---|---|
| NPC-18,FBG-18 | Experimental | Intervention drug:
NPC-18;trafermin(recombination) and gelatin spnge, combination drug FBG-18;fibrin glue
Usage:NPC-18 and FBG-18 is administered at the same time for regenerative treatment of tympanic membrane Receives: Drug: fiblast,gelatin sponge,fibrin glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of tympanic membrane perforation in the observation period at16 wks
Measured: Closure of tympanic membrane perforation in the observation period at16 wks
Secondary outcomes (5)
Closure of tympanic membrane perforation in the observation period at 4 wks
Measured: Closure of tympanic membrane perforation in the observation period at 4 wks
Improvement of hearing level in the observation period at 4 wks and 16 wks
Measured: Improvement of hearing level in the observation period at 4 wks and 16 wks
Air-bone gap in the observation period at 4 wks and 16 wks
Measured: Air-bone gap in the observation period at 4 wks and 16 wks
The difference of the average hearing level of air conduction threshold from the treatment at 0 wk and observation period at 4wks and 6 wks
Measured: The difference of the average hearing level of air conduction threshold from the treatment at 0 wk and observation period at 4wks and 6 wks
Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks
Measured: Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tympanic Membrane PerforationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shin-ichi Kanemaru, Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550314
- Sponsor's protocol ID
- TRIENT1328
- Status last verified
- Dec 2016
- First submitted
- 11 Sep 2015
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18-multicenter,Investigator Initiated Clinical Trial
- ClinicalTrials.gov ID
- NCT02550314
- Acronym / sponsor ID
- TRIENT1328
- Conditions
- Tympanic Membrane Perforation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 15 Sep 2015 (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.
To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NPC-18,FBG-18 | Experimental | Drug: fiblast,gelatin sponge,fibrin glueIntervention drug: NPC-18;trafermin(recombination) and gelatin spnge, combination drug FBG-18;fibrin glue Usage:NPC-18 and FBG-18 is administered at the same time for regenerative treatment of tympanic membrane |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed concent obtained
- At the time of obtaining informed consent, Ages ranged from over 20 to 80
- At the time of obtaining informed consent, only those with tympanic membrane perforation in 1 ear (not both) for over 6 months (perforation in both ears is excluded)
Key exclusion criteria (17 listed)
- TMP caused by burn or radiation therapy
- In patients with chronic otitis media with ear drum perforation, tympanic cavity are not dry
- Inflammatory,infection or otorrhea in patient's eardrum,earcanal,middle ear and tympanic cavity
- No invasion of epithelial and no cholesteatoma in tympanic cavity or around perforated edge
- History of tympanoplasty
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 |
|---|---|---|
| fiblast,gelatin sponge,fibrin glue | Drug | NPC-18,FBG-18 |
Primary outcome
Closure of tympanic membrane perforation in the observation period at16 wks
Time frame: Closure of tympanic membrane perforation in the observation period at16 wks
5 secondary outcomes
Closure of tympanic membrane perforation in the observation period at 4 wks
Time frame: Closure of tympanic membrane perforation in the observation period at 4 wks
Improvement of hearing level in the observation period at 4 wks and 16 wks
Time frame: Improvement of hearing level in the observation period at 4 wks and 16 wks
Air-bone gap in the observation period at 4 wks and 16 wks
Time frame: Air-bone gap in the observation period at 4 wks and 16 wks
The difference of the average hearing level of air conduction threshold from the treatment at 0 wk and observation period at 4wks and 6 wks
Time frame: The difference of the average hearing level of air conduction threshold from the treatment at 0 wk and observation period at 4wks and 6 wks
Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks
Time frame: Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks
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 22 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fiblast,gelatin sponge,fibrin glue in people with Tympanic Membrane Perforation, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, 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 17 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 22 Dec 2016. 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. 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?
Closure of tympanic membrane perforation in the observation period at16 wks (time frame: Closure of tympanic membrane perforation in the observation period at16 wks). 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 22 Dec 2016.