Trial Outcomes & Findings for A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion (NCT NCT00546117)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

2 months

Results posted on

2018-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	Prevacid Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months	Placebo Placebo SoluTab once daily for 2 months
Overall Study STARTED	9	7
Overall Study COMPLETED	5	7
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Prevacid Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months	Placebo Placebo SoluTab once daily for 2 months
Overall Study Withdrawal by Subject	3	0
Overall Study Inability to schedule follow-up visit	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prevacid n=9 Participants Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months	Placebo n=7 Participants Placebo SoluTab once daily for 2 months	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	4.82 years STANDARD_DEVIATION 1.98 • n=5 Participants	5.45 years STANDARD_DEVIATION 1.32 • n=7 Participants	5.10 years STANDARD_DEVIATION 1.86 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	7 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Outcome measures

Outcome measures
Measure	Prevacid n=9 Participants Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months	Placebo n=7 Participants Placebo SoluTab once daily for 2 months
Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear	1 participants	0 participants

PRIMARY outcome

Timeframe: 2 months

Outcome measures

Outcome measures
Measure	Prevacid n=9 Participants Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months	Placebo n=7 Participants Placebo SoluTab once daily for 2 months
Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar	1 participants	3 participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Prevacid n=9 Participants Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months	Placebo n=7 Participants Placebo SoluTab once daily for 2 months
Acoustic Reflectometry: Level of Risk as Defined by Manufacturer	2.5 level of risk Interval 1.0 to 5.0	3.5 level of risk Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prevacid n=9 Participants Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months	Placebo n=7 Participants Placebo SoluTab once daily for 2 months
Number of Participants With Normal Type A Tympanometry	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prevacid n=9 Participants Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months	Placebo n=7 Participants Placebo SoluTab once daily for 2 months
Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire	0 Participants	0 Participants

Adverse Events

Prevacid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Judith Lieu, MD

Washington University

Phone: 314-454-6162

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place