A Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18

Tympanic Membrane Perforation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550314
• Other study ID #: TRIENT1328
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2015
• Last updated: December 20, 2016
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: December 2016
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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"

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tympanic Membrane Perforation

Intervention

Drug:
• fiblast,gelatin sponge,fibrin glue

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Closure of tympanic membrane perforation in the observation period at16 wks		Closure of tympanic membrane perforation in the observation period at16 wks	No
Secondary	Closure of tympanic membrane perforation in the observation period at 4 wks		Closure of tympanic membrane perforation in the observation period at 4 wks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No