Overview

This trial is active, not recruiting.

Condition tympanic membrane perforation
Treatment fiblast,gelatin sponge,fibrin glue
Phase phase 3
Sponsor Translational Research Informatics Center, Kobe, Hyogo, Japan
Start date March 2015
End date May 2016
Trial size 20 participants
Trial identifier NCT02550314, TRIENT1328

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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
fiblast,gelatin sponge,fibrin glue

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

Inclusion Criteria: 1. Written informed concent obtained 2. At the time of obtaining informed consent, Ages ranged from over 20 to 80 3. 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: 1. TMP caused by burn or radiation therapy 2. In patients with chronic otitis media with ear drum perforation, tympanic cavity are not dry 3. Inflammatory,infection or otorrhea in patient's eardrum,earcanal,middle ear and tympanic cavity 4. No invasion of epithelial and no cholesteatoma in tympanic cavity or around perforated edge 5. History of tympanoplasty 6. A Part of the eardrum adhered to tympanic cavity 7. By temporal bone CT, soft tissue shadow in mastoid antrum or tympanic (using a CT image of less than 12 wks before patients registration) 8. Abnormality in the chain and ear ossicles 9. Air-bone gap difference more than 25dB by patch hearing test 10. Unable to see whole edge of TMP due to narrow external auditory canal 11. Unable to wash out Ear drops during the treatment period 12. Presenting with uncontrolled diabetes (NGSP HbA1c 6.9% and more) 13. Presenting with autoimmune disease 14. History of malignancy within 3 years prior to obtained informed concent 15. Administration of immunosuppressive agent or anti-cancer-agent 16. History of Allergic reaction to local anesthetic(Xylocaine), bFGF(Fiblast spray), fibrin glue(Beriplast P Combi set, etc.), gelatin sponge formulation(spongel) and others 17. 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"

Additional Information

Official title A Phase III Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18-multicenter,Investigator Initiated Clinical Trial
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Translational Research Informatics Center, Kobe, Hyogo, Japan.