A Phase III Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18-multicenter,Investigator Initiated Clinical Trial

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan0 sites20 target enrollmentMarch 2015

ConditionsTympanic Membrane Perforation

Interventionsfiblast,gelatin sponge,fibrin glue

Drugsfiblast,gelatin sponge,fibrin glue

Overview

Phase: Phase 3
Intervention: fiblast,gelatin sponge,fibrin glue
Conditions: Tympanic Membrane Perforation
Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Enrollment: 20
Primary Endpoint: Closure of tympanic membrane perforation in the observation period at16 wks
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18.

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

July 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Responsible Party

Principal Investigator

Shin-ichi Kanemaru

director

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Eligibility Criteria

Inclusion Criteria

•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)

Exclusion Criteria

•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
•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

Arms & Interventions

NPC-18,FBG-18

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

Intervention: fiblast,gelatin sponge,fibrin glue

Outcomes

Primary Outcomes

Closure of tympanic membrane perforation in the observation period at16 wks

Time Frame: Closure of tympanic membrane perforation in the observation period at16 wks

Secondary Outcomes

Improvement of hearing level in the observation period at 4 wks and 16 wks(Improvement of hearing level in the observation period at 4 wks and 16 wks)
Closure of tympanic membrane perforation in the observation period at 4 wks(Closure of tympanic membrane perforation in the observation period at 4 wks)
Air-bone gap in the observation period at 4 wks and 16 wks(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(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(Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks)