NCT03590912

Brief Summary

We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

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

July 8, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 5, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2020

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

1.4 years

First QC Date

July 8, 2018

Last Update Submit

June 17, 2020

Conditions

Otitis Media With Effusion

Outcome Measures

Primary Outcomes (1)

  • Non B type tympanogram

    one month

Secondary Outcomes (2)

  • cost of treatment

    one month

  • Adverse effects

    one month

Study Arms (4)

Wait and watch (Group D)

NO INTERVENTION

Wait and watch for 1 month

Mometasone spray (Group B)

EXPERIMENTAL

Standard dose of mometasone furoate nasal spray (one spray in each nostril once daily) for one month will be given

Drug: Mometasone 50 Mcg/Inh Nasal Spray

antibiotic + histaminic + oxymetazoline drops (Group A)

EXPERIMENTAL

This group will receive oral cefpodoxime (10 mg/kg/day in two divided dose for a week) plus oral histaminics and oxymetazoline drops. Standard dose of oral histaminics (levocetirizine, 1.25 mg for age below six years, 2.5 mg for older age) for a month plus oxymetazoline nasal drops (Nasivion 0.025%) for two weeks will be given

Drug: Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%)

Oral steroid (Group C)

EXPERIMENTAL

Patients in this group will receive one mg/kg/day of oral prednisolone (Oral steroid) in two divided dose for a week followed by half mg/kg/day in two divided dose for next one week

Drug: Steroid Drug (prednisolone)

Interventions

Mometasone 50 Mcg/Inh Nasal SprayDRUG

One spray in each nostril once daily for one month

Also known as: Metaspray nasal spray
Mometasone spray (Group B)
Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%)DRUG

Children in this group will be treated with antiboitics (syp cefpodoxime) at 10 mg/kg/day in two divided dose for a week, plus antihistamine and nasal decongestants. Oral levocetirizine (Syrup levocet 2.5 mg/5ml) 1.25 mg once daily for age up to six years, 2.5 mg once daily for elder children for a month, plus oxymetazoline (Nasivion) 0.025%, 4 drops twice daily for two weeks

Also known as: Syp Cefpodoxime, Syrup levocetirizine 2.5mg/ml; Nasivion drop
antibiotic + histaminic + oxymetazoline drops (Group A)
Steroid Drug (prednisolone)DRUG

This group will be treated with steroid drugs. Oral prednisolone, 1 mg/kg body weight daily in two divided dose for 1 week followed by half mg/kg/day in two divided dose for next one week.

Oral steroid (Group C)

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • history of mild ear ache or decreased hearing for three or more months, plus
  • intact and immobile tympanic membrane by pneumatic otoscopy
  • Type B tympanogram

You may not qualify if:

  • any external ear condition that hampers visualization of tympanic membrane
  • lost to follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lumbini Medical College

Tānsen, Palpa, 32500, Nepal

Location

Related Publications (1)

  • Mulvaney CA, Galbraith K, Webster KE, Rana M, Connolly R, Tudor-Green B, Marom T, Daniel M, Venekamp RP, Schilder AG, MacKeith S. Topical and oral steroids for otitis media with effusion (OME) in children. Cochrane Database Syst Rev. 2023 Dec 13;12(12):CD015255. doi: 10.1002/14651858.CD015255.pub2.

    PMID: 38088821DERIVED

MeSH Terms

Conditions

Otitis Media with Effusion

Interventions

Mometasone FuroateAnti-Bacterial AgentsHistamine AntagonistslevocetirizineNasal DecongestantsPrednisolone

Condition Hierarchy (Ancestors)

Otitis MediaOtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesHistamine AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPhysiological Effects of DrugsVasoconstrictor AgentsCardiovascular AgentsRespiratory System AgentsPregnadienetriols

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2018

First Posted

July 18, 2018

Study Start

September 5, 2018

Primary Completion

February 16, 2020

Study Completion

March 18, 2020

Last Updated

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share
Shared Documents
SAP, ANALYTIC CODE
Time Frame
As soon as the article is published online. Life-long

Locations

NE(1)