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

This study has been completed.

Study NCT00546117 Information provided by Washington University School of Medicine

First Received on October 17, 2007. Last Updated on September 27, 2011 History of Changes

Results First Received: December 10, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Otitis Media With Effusion
Interventions:	Drug: lansoprazole Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

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

Participant Flow: Overall Study

	Prevacid	Placebo
STARTED	9	7
COMPLETED	5	7
NOT COMPLETED	4	0
Withdrawal by Subject	3	0
Inability to schedule follow-up visit	1	0

Baseline Characteristics

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Reporting Groups

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

Baseline Measures

	Prevacid	Placebo	Total
Number of Participants [units: participants]	9	7	16
Age [units: participants]
<=18 years	9	7	16
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	4.82 ± 1.98	5.45 ± 1.32	5.10 ± 1.86
Gender [units: participants]
Female	5	1	6
Male	4	6	10
Region of Enrollment [units: participants]
United States	9	7	16

Outcome Measures

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1. Primary:

Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear [ Time Frame: 2 months ]

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2. Primary:

Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar [ Time Frame: 2 months ]

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3. Secondary:

Acoustic Reflectometry [ Time Frame: 2 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Tympanometry [ Time Frame: 2 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

5. Secondary:

Reflux Symptom Questionnaires [ Time Frame: 1 and 2 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Judith Lieu, MD
Organization: Washington University
phone: 314-454-6162
e-mail: lieuj@wustl.edu

Publications:

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

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.

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.

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.

Responsible Party:	Judith Lieu, Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00546117 History of Changes
Other Study ID Numbers:	HRPO# 07-0762
Study First Received:	October 17, 2007
Results First Received:	December 10, 2010
Last Updated:	September 27, 2011
Health Authority:	United States: Institutional Review Board