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

December 20, 2016 updated by: Shin-ichi Kanemaru, Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

September 11, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Estimate)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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