Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children

NCT01082029 | Completed Phase 4

• 1 other identifier: 07-435
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The accumulation of fluid behind the ear drum without any acute inflammation is known as otitis media with effusion (OME). It is the most common cause of acquired hearing loss during childhood. Long-term complications of OME include linguistic, developmental, and social development delays due to hearing loss. The cause of OME is not known; however, low grade infection of the middle ear, poor function of the eustachian tube between the ear and the throat, and adenoid hypertrophy have all been suggested as possible etiologies. Recent detection of the stomach enzyme pepsin in middle ear fluid has led some to propose that OME is related to the reflux of stomach contents into the ear, via the eustachian tube. The purpose of the investigators study is to determine whether anti-reflux medication may have a positive impact by clearing the accumulation of fluid in the middle ear with the aim of preventing or reducing hearing loss in children diagnosed with OME. Empiric anti-reflux therapy with proton pump inhibitor (PPI) medication is safe, proven and cost-effective. It is used widely as a diagnostic and treatment strategy in the presence of the signs and symptoms of gastroesophageal reflux disease (GERD). The signs and symptoms of GERD include heartburn, recurrent vomiting or regurgitation, acid taste in mouth, throat irritation, voice problems, heartburn, difficult or painful swallowing, asthma and recurrent pneumonia. This pilot study will be a double-blinded, randomized, placebo-controlled trial that will compare resolution rates for OME in children treated with lansoprazole or placebo for three months. At the end of the study, those patients who have persistent middle ear effusions will be brought to the operating room and have the fluid aspirated and sent for analysis for pepsin.

Conditions

Otitis Media With Effusion

Outcome Measures

Primary Outcomes (1)

• Collect the required data for sample size calculation

  The purpose of this pilot study is to collect required data for a sample size calculation for a larger clinical trial and to determine recruitment rates.

  Following the recruitment of 100 patients (~1 year)

Secondary Outcomes (1)

• Resolution of Otitis Media with Effusion

  At presentation and at 1 month, 2months and 3 months post initiation of treatment

Study Arms (2)

Lansoprazole

EXPERIMENTAL

Drug: Lansoprazole

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lansoprazole DRUG

The dosage of Lansoprazole will be administered based on guidelines set out by the prescription drug information outlined in the official Lansoprazole package insert and will remain the same for each patient during the 3 month period and is as follows: a) 1 to 11 years of age, weight less then or equal to 30 kg, 15 mg orally once daily. b) 1 to 11 years of age, weight greater then 30 kg, 30 mg orally once daily. c) 12 years of age and older, 15 mg orally once daily. The doses of Lansoprazole will be prepared in liquid form by the Inpatient Pharmacy at Hamilton Health Sciences.

Also known as: Prevacid

Lansoprazole

Placebo DRUG

Lactose powder in 8.4% Sodium Bicarbonate (Liquid placebo)

Placebo

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 1 and 17 years referred to the McMaster Otolaryngology Clinic.
• Presence of bilateral OME for at least 3 months based on:
• Clinical history: patient may present with decrease in hearing, aural fullness and/or ear pressure, balance problems, ear tugging/rubbing, they typically do not have otalgia or fever.
• Pneumatic otoscopy: observations suggestive of OME include presence of a dull tympanic membrane with presence of non purulent effusion (serous or mucoid), presence of a level of effusion, decrease or non motility of the tympanic membrane, retraction of the tympanic membrane.
• Tympanometry: type B or type C tympanogram with normal air volume of the external auditory canal.
• Pure tone audiometry: conductive hearing loss that typically varies from slight to moderate.

You may not qualify if:

• Presence of acute otitis media as determined by history and physical examination:
• History of rapid acute onset of significant otalgia, decrease in hearing, fever, irritability.
• Pneumatic otoscopy revealing purulent effusion, yellowness and/or redness with hypervascularity of the tympanic membrane, bulging of tympanic membrane with decrease of normal landmarks.
• Presence of craniofacial abnormalities
• Previous middle ear surgery (excluding myringotomy and tube)
• Allergic reactions to lansoprazole, and any other adverse drug interactions to lansoprazole.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• McMaster University: collaborator

Study Sites (1)

Mcmaster University Medical Centre 3V1 Clinic

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (27)

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  BACKGROUND

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MeSH Terms

Conditions

Otitis Media with Effusion

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dr. Diane Reid, MD FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

• Dr. Gavin Rukholm, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Gavin Rukholm, MD FRCSC

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 5, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

CA (1)