A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion

NCT00546117 | Completed Results DMC

• 1 other identifier: HRPO# 07-0762
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to see if reflux of stomach fluid might be a cause of chronic fluid in the ears. Our hypothesis is that treatment with an anti-reflux medication (lansoprazole) will increase the rate of resolution of chronic middle ear fluid in children.

Conditions

Otitis Media With Effusion

Keywords

otitis media with effusion; gastroesophageal reflux; ear infection; proton pump inhibitor

Outcome Measures

Primary Outcomes (2)

• Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear

  2 months

• Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar

  2 months

Secondary Outcomes (3)

• Acoustic Reflectometry: Level of Risk as Defined by Manufacturer

  2 months

• Number of Participants With Normal Type A Tympanometry

  2 months

• Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire

  2 months

Study Arms (2)

Lansoprazole (Prevacid)

EXPERIMENTAL

Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months

Drug: lansoprazole

Placebo

PLACEBO COMPARATOR

Placebo SoluTab once daily for 2 months

Drug: placebo

Interventions

lansoprazole DRUG

Prevacid SoluTab 15 mg daily by mouth for 2 months (patients weighing 10-30 kg),or Prevacid SoluTab 30 mg daily by mouth for 2 months (patients weighing \>30 kg) is the experimental arm. Placebo Solutabs will be given in the same dosage, frequency, and duration for the placebo arm.

Also known as: Prevacid SoluTab

Lansoprazole (Prevacid)

placebo DRUG

Placebo Solutab in 15 and 30 mg dosages.

Also known as: Placebo Solutab

Placebo

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• History of chronic otitis media with effusion meeting clinical indications for tympanostomy tubes placement, defined as the presence of middle ear fluid on physical exam for at least 3 months, in at least one ear.

You may not qualify if:

• Past medical history or concurrent conditions known to increase the incidence of either recurrent otitis media or otitis media with effusion or gastroesophageal reflux disease, including cleft palate, neurological delay, cerebral palsy, Down syndrome, velocardiofacial syndrome, and primary ciliary dyskinesia.
• Children with structural abnormalities of the tympanic membranes, such as cholesteatoma, deep retraction pockets, and atelectasis of the tympanic membrane. These abnormalities would require placement of tympanostomy tubes in standard clinical practice.
• Children weighing less than 10 kilograms, due to the lower weight limit for standard Prevacid™ dosing

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Doris Duke Charitable Foundation: collaborator
• TAP Pharmaceutical Products Inc.: collaborator

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

• Lieu JE, Muthappan PG, Uppaluri R. Association of reflux with otitis media in children. Otolaryngol Head Neck Surg. 2005 Sep;133(3):357-61. doi: 10.1016/j.otohns.2005.05.654.

  PMID: 16143181 BACKGROUND

• Tasker A, Dettmar PW, Panetti M, Koufman JA, P Birchall J, Pearson JP. Is gastric reflux a cause of otitis media with effusion in children? Laryngoscope. 2002 Nov;112(11):1930-4. doi: 10.1097/00005537-200211000-00004.

  PMID: 12439157 BACKGROUND

• Abd El-Fattah AM, Abdul Maksoud GA, Ramadan AS, Abdalla AF, Abdel Aziz MM. Pepsin assay: a marker for reflux in pediatric glue ear. Otolaryngol Head Neck Surg. 2007 Mar;136(3):464-70. doi: 10.1016/j.otohns.2006.08.030.

  PMID: 17321879 BACKGROUND

• Sone M, Yamamuro Y, Hayashi H, Yanagi E, Niwa Y, Nakashima T. Prediction of gastroesophageal reflux in otitis media with effusion in adults. Acta Otolaryngol. 2007 May;127(5):470-3. doi: 10.1080/00016480600868406.

  PMID: 17453471 BACKGROUND

MeSH Terms

Conditions

Otitis Media with Effusion; Gastroesophageal Reflux; Otitis

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Otitis Media; Ear Diseases; Otorhinolaryngologic Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System 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

Results Point of Contact

• Title: Judith Lieu, MD
• Organization: Washington University

lieuj@wustl.edu

314-454-6162

Study Officials

• Judith EC Lieu, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: Assistant Professor

Study Record Dates

• First Submitted: October 17, 2007
• First Posted: October 18, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 1, 2018
• Results First Posted: January 11, 2011

Record last verified: 2018-05

Locations

US (1)