NCT02550314

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

September 11, 2015

Last Update Submit

December 20, 2016

Conditions

Tympanic Membrane Perforation

Outcome Measures

Primary Outcomes (1)

  • Closure of tympanic membrane perforation in the observation period at16 wks

    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

    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

    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

    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

Study Arms (1)

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

Drug: fiblast,gelatin sponge,fibrin glue

Interventions

fiblast,gelatin sponge,fibrin glueDRUG
NPC-18,FBG-18

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesWounds and Injuries

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 15, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

December 22, 2016

Record last verified: 2016-12