NCT01967498

Brief Summary

The purpose of our double-blind, placebo controlled study is to test the hypothesis that montelukast therapy might be associated with improved hearing in certain sub populations of children suffering from OME.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

Enrollment Period

2.1 years

First QC Date

October 17, 2013

Last Update Submit

October 17, 2013

Conditions

Chronic Otitis Media With EffusionConductive Hearing Loss

Keywords

chronic otitis media with effusionconductive hearing loss

Outcome Measures

Primary Outcomes (1)

  • improvement of hearing of 10 db based on pure tone audiometry

    3 months

Secondary Outcomes (1)

  • improvement of tympanometry graph to type A

    3 months

Study Arms (2)

montelukast

EXPERIMENTAL

this arm will receive montelukast as the active intervention of the study

Drug: Montelukast

placebo

PLACEBO COMPARATOR

Interventions

MontelukastDRUG
Also known as: Singulair
montelukast

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Documented persistent OME of at least 3 months (otoscopy or audiometry or tympanometry)
  • Patients between the ages of 2-10 being evaluated for VT surgery
  • Tympanogram type B
  • A conductive hearing loss greater than 20 DB
  • Otoscopy confirming middle ear effusion

You may not qualify if:

  • previous adenoidectomy or tonsillectomy
  • history of ear surgery
  • cleft palate, Down's syndrome, congenital, malformations of the ear or cholesteatoma
  • Sensoneural hearing loss
  • Allergy to montelukast
  • Moderate or Severe OSA requiring surgery sooner than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hearing Loss, Conductive

Interventions

montelukast

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2013

First Posted

October 23, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

October 23, 2013

Record last verified: 2013-10