A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion
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|ClinicalTrials.gov Identifier: NCT00546117|
Recruitment Status : Completed
First Posted : October 18, 2007
Results First Posted : January 11, 2011
Last Update Posted : June 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Otitis Media With Effusion||Drug: lansoprazole Drug: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
Experimental: Lansoprazole (Prevacid)
Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
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.
Other Name: Prevacid SoluTab
Placebo Comparator: Placebo
Placebo SoluTab once daily for 2 months
Placebo Solutab in 15 and 30 mg dosages.
Other Name: Placebo Solutab
- Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear [ Time Frame: 2 months ]
- Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar [ Time Frame: 2 months ]
- Acoustic Reflectometry: Level of Risk as Defined by Manufacturer [ Time Frame: 2 months ]Spectral gradient acoustic reflectometry is a noninvasive, non-audible acoustic wave used to help detect middle ear fluid. The manufacturer recommends interpretation of the angle result as: <49°, high risk of middle ear effusion (level 5); 49-59°, moderate-high risk (level 4); 60-69°, moderate risk (level 3); 70-95°, low-moderate risk (level 2) and >95°, low risk (level 1).
- Number of Participants With Normal Type A Tympanometry [ Time Frame: 2 months ]
Tympanometry of both ears, coded by Jerger classification (Type A, normal; type B, flat; Type C; negative pressure).
This is a standard test of middle ear status as performed by audiologists. Please refer to the reference for more information: Kileny & Zwolan, Diagnostic Audiology, chapter 133, Cummings Otolaryngology-Head and Neck Surgery, Elsevier/Saunders, 2015.
- Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire [ Time Frame: 2 months ]Questions regarding reflux symptoms, created and evaluated by Nelson et al, Prevalence of symptoms of gastroesophageal reflux during childhood: a pediatric practice-based survey, Arch Pediatr Adolesc Med 2000;154;150-154. This study used the GER3-9P version for children aged 3-9 years. Results are reported as number reporting at least one specific symptom in the past week, maximum 7 symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546117
|United States, Missouri|
|St. Louis Children's Hospital|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Judith EC Lieu, MD||Washington University School of Medicine|