Trial · NCT00546117
A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion
NCT00546117, Not applicable, Completed, Washington University School of Medicine; results first posted 2011-01-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion. Trials, record NCT00546117. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00546117
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion
- NCT number
- NCT00546117
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 16 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Otitis Media With Effusion
- Interventions
- lansoprazole, placebo
- First posted
- 2007-10-18
- Last updated
- 2018-06-01
- Results first posted
- 2011-01-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear | 2 months | |
| Primary | Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar | 2 months | |
| Secondary | Acoustic Reflectometry: Level of Risk as Defined by Manufacturer | 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). |
| Secondary | Number of Participants With Normal Type A Tympanometry | 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. |
| Secondary | Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear | 2 months | participants | NUMBER | |
| PRIMARY | Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar | 2 months | participants | NUMBER | |
| SECONDARY | Acoustic Reflectometry: Level of Risk as Defined by Manufacturer | 2 months | level of risk | MEAN | |
| SECONDARY | Number of Participants With Normal Type A Tympanometry | 2 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire | 2 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear | Prevacid | 1 | participants | ||
| Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear | Placebo | 0 | participants | ||
| Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar | Prevacid | 1 | participants | ||
| Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar | Placebo | 3 | participants | ||
| Acoustic Reflectometry: Level of Risk as Defined by Manufacturer | Lansoprazole (Prevacid) | 2.5 | Full Range 1 to 5 | level of risk | |
| Acoustic Reflectometry: Level of Risk as Defined by Manufacturer | Placebo | 3.5 | Full Range 1 to 5 | level of risk | |
| Number of Participants With Normal Type A Tympanometry | Lansoprazole (Prevacid) | 0 | Participants | ||
| Number of Participants With Normal Type A Tympanometry | Placebo | 0 | Participants | ||
| Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire | Lansoprazole (Prevacid) | 0 | Participants | ||
| Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire | Placebo | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prevacid | 9 | |
| Overall Study | STARTED | Placebo | 7 | |
| Overall Study | COMPLETED | Prevacid | 5 | |
| Overall Study | COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Prevacid | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prevacid | 0 | 9 |
| Total, all-cause mortality | Placebo | 0 | 7 |
| Total, other adverse events | Prevacid | 0 | 9 |
| Total, other adverse events | Placebo | 0 | 7 |
| Total, serious adverse events | Prevacid | 0 | 9 |
| Total, serious adverse events | Placebo | 0 | 7 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prevacid vs Placebo: Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar | Trial comparisons |
| Lansoprazole (Prevacid) vs Placebo: Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire | Trial comparisons |
| Lansoprazole (Prevacid) vs Placebo: Number of Participants With Normal Type A Tympanometry | Trial comparisons |
| Prevacid vs Placebo: Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear | Trial comparisons |
| Prevacid vs Placebo: deaths from any cause | Trial comparisons |
| Prevacid vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00546117
GET https://conductscience.org/api/trials/v1/NCT00546117/registered